Atlas FDA

1997

4,309 FDA 510(k) clearances · Clearance year

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

RecordFirmDate
INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL (K965040)Johnson & Johnson Medical, Inc.1997-03-10
ROUND WINDOW CATH (K965115)Neuro-Biometrix, Inc.1997-03-10
MITEK SUTURE RETROGRADER (K970360)Mitek Products1997-03-10
ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS (K964909)Xomed, Inc.1997-03-10
PULSEMASTER (K961269)American Dental Technologies, Inc.1997-03-10
TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL (K970100)Simplicity Diagnostics, Inc.1997-03-10
FLAT CLOSED WOUND DRAIN WITH TROCAR (K965146)Axiom Medical, Inc.1997-03-10
PVK-720ST ENDOCAVITARY TRANSDUCER (K964865)Toshiba America Medical Systems, In.C1997-03-10
AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERS (K964910)Alpha-Omega Services, Inc.1997-03-10
GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR (K964973)Gish Biomedical, Inc.1997-03-10
R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM (K964538)Boston Scientific Corp1997-03-10
BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION (K964604)Biotronik, Inc.1997-03-10
SPARFLOZACIN, 5 MCG, SENSI-DISC (K970385)Becton Dickinson Microbiology Systems1997-03-10
PRESBYTERIAN LINEN SERVICES SURGICAL PACKS (K970286)Medline Industries, Inc.1997-03-10
SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L (K965240)Beckman Instruments, Inc.1997-03-10
HUMAN CHORIONIC GONADOTROPIN METHOD (K970387)Dade Chemistry Systems, Inc.1997-03-10
HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY (K962730)Hycor Biomedical, Inc.1997-03-07
SPECKTIN-LA TEST SET (K961892)Analytical Control Systems, Inc.1997-03-07
HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY (K962578)Hycor Biomedical, Inc.1997-03-07
HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODY (K962727)Hycor Biomedical, Inc.1997-03-07
(LENSES) BENZ-G 3X (HIOXIFILCON B) SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE TINT (K964528)Benz Research and Development Corp.1997-03-07
HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY (K962720)Hycor Biomedical, Inc.1997-03-07
HYCOR HY.TEC/MANUAL JO-1 AUTO-ANTIBODY (K962731)Hycor Biomedical, Inc.1997-03-07
HYCOR HY.TEC/MANUAL SS-A AUTO-ANTIBODY (K962719)Hycor Biomedical, Inc.1997-03-07
DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE (K962545)Sterilization Cassette Systems, Inc.1997-03-07
OMEGA TOTAL HIP SYSTEM FOR USE WITHOUT BONE CEMENT (LINE EXTENSION) (K964924)Osteoimplant Technology, Inc.1997-03-07
HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY (K962729)Hycor Biomedical, Inc.1997-03-07
SHARPLAN RUBY LASER SYSTEM (K962446)Sharplan Lasers, Inc.1997-03-07
HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY (K962722)Hycor Biomedical, Inc.1997-03-07
HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY (K962728)Hycor Biomedical, Inc.1997-03-07
MODEL 700 (K944180)Memtec Corp.1997-03-07
THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS (K964939)Creative Biomedics, Inc.1997-03-06
ELECSYS CALCHECK CEA (K970459)Boehringer Mannheim Corp.1997-03-06
ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE) (K951632)Ortho Diagnostic Systems, Inc.1997-03-06
LIPASE REAGENT SET (COLIPASE METHOD) (K970124)Teco Diagnostics1997-03-06
SENTURA SURGICAL GLOVES (K964962)Maxxim Medical1997-03-06
CARDIOSERV P (K962547)Marquette Electronics, Inc.1997-03-06
ROLLER ELECTRODE (K954488)Olympus America, Inc.1997-03-06
DUAL SLIM PORT IMPLANTED PORT (0654970/0654940) (K964066)C.R. Bard, Inc.1997-03-06
EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST (K970424)Excel Scientific, Inc.1997-03-06
CR PERFECT (K970087)Chimera Research & Chemical, Inc.1997-03-06
QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES (K970391)Contour Medical Technology, Inc.1997-03-06
COULTER AC.T SERIES ANALYZER (K964988)Coulter Corp.1997-03-06
ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE (K964609)Array Medical, Inc.1997-03-06
SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE (K962327)Sekure Seat Corp.1997-03-06
SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX (K960072)Biochem Immunosystems (U.S.), Inc.1997-03-06
SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT (K965108)Beckman Instruments, Inc.1997-03-06
ELECSYS CALCHECK CEA (K970452)Boehringer Mannheim Corp.1997-03-06
IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES (K965055)Imagyn Medical, Inc.1997-03-06
2.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0OMM SEMI-RIGID NEUROVIEW GRASPING FORCEPS (K965078)Neuro Navigational Corp.1997-03-06
BIOCOR 200 HIGH PERFORMANCEOXYGENATOR (K964967)Minntech Corp.1997-03-06
ELECSYS CALCHECK PSA (K970458)Boehringer Mannheim Corp.1997-03-06
LEVOFLOXACIN, 5MCG, SENSI-DISC (K970212)Becton Dickinson Microbiology Systems1997-03-06
MEDICOM, TENS ELECTRODES (K965194)Medicotest A/S1997-03-06
COROMETRICS MODEL 510 AND 511 MONITOR (K962781)Ge Medical Systems Information Technologies1997-03-06
ELIAS ANA-HEP-2 (K964385)Elias U.S.A., Inc.1997-03-06
IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN (K963974)Beckman Instruments, Inc.1997-03-06
EZ SURE URINE DIPSTICK PREGNANCY HOME TEST (K970425)Excel Scientific, Inc.1997-03-06
ANATOM 2000 (K964890)Analogic Corp.1997-03-06
ULTREX POWDER-FREE SURGICAL GLOVES/ULTREX POWDER-FREE SURGICAL GLOVES WITH LOW PROTEIN CLAIM (K964980)Maxxim Medical1997-03-06
IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT (K964843)Beckman Instruments, Inc.1997-03-06
SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M. (K965070)Mecta Corp.1997-03-06
MEDLINE CIRCUMCISION TRAY (K970282)Medline1997-03-06
SOLARO 33 (K970045)Metalor Dental USA Corp.1997-03-05
REPLACE TITANIUM IMPLANT SYSTEM (K964220)Steri-Oss, Inc.1997-03-05
STERILE WATER PUMP (K970002)Micro Motors, Inc.1997-03-05
PS-41 6M PATIENT SIMULATOR (K963198)Metron U.S., Inc.1997-03-05
KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY (K970055)KARL STORZ Endoscopy-America, Inc.1997-03-05
LATEX EXAM GLOVES (K965155)P.T. Irama Dinamika Latex1997-03-05
BIOJECTOR 2000 MODEL 1B02000 (K960373)Bioject, Inc.1997-03-05
AUROFLUID 22 (K970044)Metalor Dental USA Corp.1997-03-05
V-CATH (K964966)Hdc Corp.1997-03-05
S-SCORT (2500) (K964997)Sscor1997-03-05
EPILASER NORMAL MODE RUBY LASER (K963947)Spectrum Medical Technologies, Inc.1997-03-05
BIOPSY TRAY (K970152)Medcare Medical Group, Inc.1997-03-05
EZTEST-GAS (K930683)Sgm Biomedical, Inc.1997-03-04
PHASED ARRAY TRANSDUCER - - PSK-20CT (K970047)Toshiba America Medical Systems, In.C1997-03-04
NOAH MONITORING ELECTRODE SYSTEM (K970125)Contour Medical Technology, Inc.1997-03-04
NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS (K954676)Nissho Corp.1997-03-04
CPI, MAXI-VAC(6480),THOMAS INDUSTRIES, MEDI-PUMP(1240/1242/1243) (K965059)Thomas Industries1997-03-04
EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD (K964855)Shippert Medical Technologies Corp.1997-03-04
RIWO CUT-MORCELLATOR EXISTING OF KNIFE/CUTTING SLEEVE/PROTECTION SLEEVE/CLAW GRASPING FORCEPS (K970105)Richard Wolf Medical Instruments Corp.1997-03-04
CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE (K965023)Scimed Life Systems, Inc.1997-03-04
BRANNON ARTERIO-VENOUS PORTSYRINGE (K965030)Vascular Logics, Inc.1997-03-04
AUTOSTATTMII ANTI-DSDNA (K952567)Cogent Diagnotics , Ltd.1997-03-04
STRYKER ENCORE STERILIZER (K962755)Stryker Corp.1997-03-04
OXIMETRIX 4 COMPUTER SYSTEM (K961661)Abbott Laboratories1997-03-04
PNEUMATIC ARTHROSCOPY PULSED IRRIGATOR SYSTEM MODEL 0027030 AND BATTERY ARTHROSCOPY PULSED IRRIGATOR SYSTEM (K964879)Davol Inc., Sub. C. R. Bard, Inc.1997-03-04
FLEXILOG 3000 (K964589)Oakfield Instruments, Ltd.1997-03-04
PERIPHERALLY INSERTED MEDLINE CATHETER (K963257)Arrow Intl., Inc.1997-03-04
MD-1835 (K964806)Fischer Imaging Corp.1997-03-04
PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS (K965176)Pilling Weck Group1997-03-04
IMAGER TORQUE CATHETER (K965229)Boston Scientific Corp1997-03-04
DENTSPLY PRECISION TORQUE SYSTEM (K964046)Dentsply Intl.1997-03-04
JAMES ALEX SUNGLASSES (K970101)D&K Stores, Inc.1997-03-04
MMB CALIBRATOR (K970336)Dade Chemistry Systems, Inc.1997-03-03
MARK 20 AND MARK 25 HAND ENGINE CONTROLLER (K964860)Bell Intl., Inc.1997-03-03
SAFETEX COMBINATION BLOOD (ALCOHOL, ETHYL) / URINE COLLECTION AND TRANSPORT KIT (K964698)Andwin Scientific1997-03-03
PROCEDURE SPECIFIC KITS (K964168)Sage Products, Inc.1997-03-03
ABBOTT HCG SERUM CONTROLS (K970527)Abbott Laboratories1997-03-03
← Previous Next →

Track 1997 automatically

Every clearance here is in the API, with alerts when new ones post.