Atlas FDA

1988

4,299 FDA 510(k) clearances · Clearance year

Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
EXEL 2002 & 2002FS CT SCANNER (K884669)Elscint, Inc.1988-12-30
DADE FACTOR IX CHROMOGENIC ASSAY (K884551)Baxter Healthcare Corp1988-12-30
TRANSFER CONTAINER HUMIDIFIER (K881648)Newport Biosystems, Inc.1988-12-30
DADE FACTOR VIII CHROMOGENIC ASSAY (K884544)Baxter Healthcare Corp1988-12-30
INFUSION PUMP (K882830)Pemlab Corp.1988-12-30
EXEL 905 SERIES CT SCANNER (K884667)Elscint, Inc.1988-12-30
COAG-A-MATE XC/XC PLUS VERSION D.00 SOFTWARE (K885076)Organon Teknika Corp.1988-12-30
EXEL 1002 CT SCANNER (K884668)Elscint, Inc.1988-12-30
DIOPTICS EYESHIELDS (K885163)Dioptics1988-12-30
AE-800PA EEG MODULE (K884537)Nihon Kohden America, Inc.1988-12-29
BEHRING POLAROID OPUS THEOPHYLLINE (K885044)Pb Diagnostic Systems, Inc.1988-12-29
MODIFIED NEW JERSEY ACETABULAR COMP. & BONE SCREWS (K884888)Protek, Inc.1988-12-29
MODIFIED CHICK AMBULATORY HALO (K884242)Chick Medical Products1988-12-29
VIRGO(R) MICROWELL ALT ASSAY (K884784)Electro-Nucleonics, Inc.1988-12-29
VISUAL BLOOD GLUCOSE TEST SYSTEM (K884993)Diagnostic Systems1988-12-29
NEURAL MAGNETIC STIMULATOR, THE D190 (K883340)Tracor Northern, Inc.1988-12-29
ROGOZINSKI SPINAL SYSTEM (K884263)Richards Medical Co., Inc.1988-12-29
CLENSATRON AUTOMATIC CONTACT LENS CLEANER (K884414)Questech Intl., Inc.1988-12-29
SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER (K884035)Sclavo, Inc.1988-12-29
FIBRI-PREST/THROMBIN-PREST CONTROLS (K884385)American Bioproducts Co.1988-12-28
EDENTRACE MULTI-CHARTER MODEL 3700 (K883315)Edentec Corp.1988-12-28
THROMBIN-PREST REAGENT KIT (K884384)American Bioproducts Co.1988-12-28
CARDIOCAP(TM) CM-104 MONITOR (K884955)Datex Division Instrumentarium Corp.1988-12-28
PERFECTA II TOTAL HIP SYSTEM (K883618)Orthomet, Inc.1988-12-28
ALLERGAN LENS CASE (K884251)Allergan Optical1988-12-28
COULTER STKS (K885093)Coulter Electronics, Inc.1988-12-28
PROCEDURE PACKS CONTRAST MEDIA SETS (K882717)Procedure Packs, Inc.1988-12-28
KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT (K884485)King Diagnostics, Inc.1988-12-28
OC-100 OXIMETER INTERFACE CALIBRATOR (K884891)Telediagnostic Systems, Inc.1988-12-28
CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE (K884153)Candela Laser Corp.1988-12-28
UNIREST PL, ANTE./POST. RESTORATIVE, PASTE/LIQUID (K884351)Scientific Pharmaceuticals, Inc.1988-12-28
FACSMATE SAMPLE HANDLING DEVICE (K885132)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-12-28
CELL SCRAPER (K885121)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-12-28
LIFEPAK 50 MONITOR/DEFIBRILLATOR (K883617)Physio-Control Corp.1988-12-28
ULTRAFLOTATION MEDICAL WHEELCHAIR (K884908)Medical Flotation Systems, Inc.1988-12-27
SURGICAL CLAMP INSERTS (K883790)Applied Vascular Devices, Inc.1988-12-27
PROPAQ 106(TM) (K884320)Protocol Systems, Inc.1988-12-27
CELL SAVER HAEMOLITE B AUTO. BLOOD RECOVERY SYSTEM (K883934)Haemonetics Corp.1988-12-27
NEBULIZER HEATER (K882935)Automatic Liquid Packaging, Inc.1988-12-27
MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN (K884347)Advanced Surgical Products, Inc.1988-12-27
SLIDING ARM SUPPORT (K885105)Rolcontrol Products, Co., Inc.1988-12-27
FERRITIN SEROZYME IMMUNOENZYMETRIC ASSAY (K884683)Serono-Baker Diagnostics, Inc.1988-12-27
MODIFIED Q-SERIES OF TREADMILLS (K885062)Quinton, Inc.1988-12-27
CARDIOCAP(TM) CTO-104 MONITOR (K884956)Datex Division Instrumentarium Corp.1988-12-27
ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE (K884862)Anchor Products Co.1988-12-27
KARMA-RS, KARMA-FS WHEELCHAIRS (K884812)Orthofab, Inc.1988-12-27
LAYDOWN ARM SUPPORT MECHANISM (K885104)Rolcontrol Products, Co., Inc.1988-12-27
ABBOTT SPECTRUM(R) BICARBONATE REAGENT (K884821)Abbott Laboratories1988-12-27
SURGICAL SPRING CLIPS (K883909)Applied Vascular Devices, Inc.1988-12-27
PHARMASEAL STERILE WOUND CARE DRESSING (K884397)Baxter Healthcare Corp1988-12-27
REMOVABLE BATTERY POWER SYSTEM (K885106)Rolcontrol Products, Co., Inc.1988-12-27
BUMPY MEDICAL MASSAGE MAT (K884907)Medical Flotation Systems, Inc.1988-12-27
KVM BLOOD CELL COUNTER (K884471)Kvm Instruments, Inc.1988-12-27
ECG/RESPIRATION/ARRHYTHMIA MODULE FOR RM-301 (K880505)Ppg Industries, Inc.1988-12-27
TRANSLUMINAL ENDARTERECTOMY DEVICE (K884154)Thomas J. Fogarty, M.D.1988-12-27
1600 LIGHT TOUCH CONTROL (K885103)Rolcontrol Products, Co., Inc.1988-12-27
MODIFIED SHILEY FEMORAL ARTERIAL CANNULA (K884393)Shiley, Inc.1988-12-27
CYTO-STAT/COULTER CLONE T11-RD1/B1-FITC MONO. ANTI (K884346)Coulter Immunology1988-12-27
BUCHBINDER MULTIFLEX GUIDEWIRE (K884274)Medtronic Vascular1988-12-27
Q5000 ST/HR SLOPE MODIFICATION (K883468)Quinton, Inc.1988-12-27
LABILE LYSING REAGENT (K884315)Helena Laboratories1988-12-27
MEDITRODE KIT (K882554)Life-Tech Intl., Inc.1988-12-23
PMT MODEL 1110-5 PMT PERITONEAL CATHETER (K884036)Pmt Corp.1988-12-22
SLT CLMD CONTACT LASER (K884815)Surgical Laser Technologies, Inc.1988-12-22
COMPAX MODEL 40, 400, 400T (K884930)General Electric Co.1988-12-22
BOVAC SMOKE COLLECTOR (K884641)Orthopedic Systems, Inc.1988-12-22
SONY TRINITRON COLOR VIDEO MONITOR PVM-1343MD (K885042)Sony Medical Electronics Co.1988-12-22
COTUBE LH IRMA ASSAY (K884498)Bio-Rad1988-12-22
ORTHO* SYPHILIS-G ANTIBODY ELISA TEST (K883939)Ortho Diagnostic Systems, Inc.1988-12-22
OCCLUSAL HARMONY IMPRESSION TRAY (K884316)Advantage Dental Co.1988-12-22
MODEL WC-115 MOBILE BASSINET (K884285)Gempco, Inc.1988-12-22
STERA DISPOSABLE SYRINGES (K881791)Excel U.S.A.1988-12-22
FLEXIFLO INTRODUCER (DIRECT STICK) GASTROSTOMY KIT (K884275)Abbott Laboratories1988-12-22
LEVINIUM (K884257)Ticomet Engineering & Consulting1988-12-22
LIQUID CHROMATOGRAPHY COLUMNS SOLID PHASE EX. TUBE (K884403)Supelco, Inc.1988-12-22
SMILE-DENT ANTE./POST. RESTORATIVE, LIGHT-CURED (K884352)Scientific Pharmaceuticals, Inc.1988-12-22
INDENTEC DRILL RA #1 (K884187)Phillip C. Crawford, D.D.S.1988-12-22
MODEL WC-107 MOBILE NEWBORN BED (K884283)Gempco, Inc.1988-12-22
HEMODIALYSIS CONCENTRATES (K883068)Dove Medical Supplies1988-12-22
AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT (K883123)Amersham Corp.1988-12-22
ADAC VIEWPOINT (ADDITIONAL SOFTWARE) (K884349)Adac Laboratories1988-12-22
HEMORX COLD PACK (K883984)Bio-Dyne, Inc.1988-12-22
AD POST (K884277)J. Morita USA, Inc.1988-12-22
GROUP A STREP, BETA-STREP (K884750)Ampcor, Inc.1988-12-22
MODEL WC-102 NEWBORN BED & EQUIPMENT CABINET (K884280)Gempco, Inc.1988-12-22
GAUZE SPONGE (K884826)Medical Action Industries, Inc.1988-12-22
ORTHO* SYPHILIS-M ANTIBODY ELISA TEST (K883938)Ortho Diagnostic Systems, Inc.1988-12-22
USCI(R) HEMAQUET(TM) INTRODUCER W/OBTURATOR (K884104)C.R. Bard, Inc.1988-12-21
CMS RECORD AND VERIFY SYSTEM (K882484)Computerized Medical Systems, Inc.1988-12-21
ACS(R) HI-TORQUE GOLD(TM) GUIDE WIRE (K884262)Advanced Cardiovascular Systems, Inc.1988-12-21
MT/S (SOFTWARE RELEASE 3.1) (K884607)Diasonics, Inc.1988-12-21
INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER (K884390)Medtronic Blood Systems, Inc.1988-12-21
USCI DORROS INFUSION/PROBING CATHETER (K884209)Usci, Div. C.R. Bard, Inc.1988-12-21
BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SET (K884129)Bio Medicus, Inc.1988-12-21
VARIABLE KV INTREX VSK 60 - 90 KVP (K883354)Keystone X-Ray, Inc.1988-12-21
QM300 PCR ANTIBODY PACK (K885001)Kallestad Diag, A Div. of Erbamont, Inc.1988-12-20
AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH MEDIUM #3 (K880587)C.I.S.A. Import Export C/O Larson and Taylor1988-12-20
ERA 2000 EMERGENCY RESUSCITATOR (K884089)Neotronics Medical , Ltd.1988-12-20
MAXITHINS SUPER PADS, DEODORANT (K884446)Tambrands, Inc.1988-12-20
KOTEX STICK TAMPONS, REGULAR AND SUPER (K884305)Kimberly-Clark Corp.1988-12-20
Next →

Track 1988 automatically

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