Atlas FDA

1988

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

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RecordFirmDate
GENESIS II TRANSCRANIAL PROBE (K883238)Biosound, Inc.1988-08-24
522 INTELLIGENT PUMP (K882159)Kendall Mcgaw Laboratories, Inc.1988-08-24
PRISTINE XTRA, SURGEON'S GLOVE (K883244)Japan World Medical Supply1988-08-23
BD MICROFINE IV PEN INJECTOR (K881775)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-08-23
GE INTEGRATED DIAGNOSTIC SYSTEM (DRS.PRS) (K873121)General Electric Co.1988-08-23
LASER MIXTURE (K882942)Swisco, Inc.1988-08-23
EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95 (K882766)Em Diagnostic Systems, Inc.1988-08-23
SUTURE RETENTION DEVICE (K883299)Edwards Orthopaedics Div., Baxter Healthcare Corp.1988-08-23
GASTROSTOMY FEEDING TUBE (K883336)Gastrotech, Inc.1988-08-23
MODEL 1080 ROLLER MASSAGE TABLE (K883357)Excel Medical Products, Inc.1988-08-23
CHOP SPINE FRAME (K883295)Avec Scientific Design Corp.1988-08-23
ENDO-ICE (K881826)The Hygenic Corp.1988-08-23
SURGICAL SEALANT APPLICATOR (K883338)Micromedics, Inc.1988-08-23
PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING TUBE (K883351)Gastrotech, Inc.1988-08-23
MASSAGE MACHINE (CAT. EM-01 ULE 111756) (K883064)Emrad, Ltd.1988-08-23
AMISCO U-100 INSULIN SYRINGE (K882114)American Intl. Medical Supply Co.1988-08-23
MD STRIPS BG (K875049)Amatech International, Inc.1988-08-23
MODEL 5050 SURGILASER FOR OB-GYN USE (K871875)Lasermatic, Inc.1988-08-22
B & B I/A HANDPIECE (K881517)B&B Medical Assoc., Inc.1988-08-22
SUNGLASSES (K872786)Quality Sunglasses, Ltd.1988-08-22
RETRACTIVE INCISION MICROMETER (RIM) GUAGE (K882402)Optical Center1988-08-22
IOL IMPLANTATION FORCEPS (K883197)D & D Surgical1988-08-22
EV MONOCANALICULAR STENT (TM) (K883233)Eagle Vision, Inc.1988-08-22
INFUSION HANDLE (K881518)B&B Medical Assoc., Inc.1988-08-22
ECG MONITOR AND RESPIRATION PACER (K881055)D. E. Hokanson, Inc.1988-08-19
NIDEK US-3000 (K882162)Nidek, Inc.1988-08-19
OXYGEN/TEMPERATURE ANALYZER MODEL 300 SERIES (K881663)Salter Labs1988-08-19
LARYNGOSCOPE BLADES (K883414)Truphatek, Ltd.1988-08-19
LUHR MICRO SYSTEM (K882454)Howmedica Corp.1988-08-19
TAPER FLEX-TIP STEERABLE GUIDEWIRE (K880762)Target Therapeutics1988-08-19
ATH METAL:UHMWPE TOTAL HIP SYSTEM (K882675)Kinamed, Inc.1988-08-19
3000 PHYSIOLOGICAL MONITOR (K880301)Datascope Corp.1988-08-19
MEDA ONE-STEP (K882943)Medical Electronic Assn.1988-08-19
COATING FOR WIRE GUIDE (K880722)Cook, Inc.1988-08-19
TAPER-22 STEERABLE GUIDEWIRE (K880761)Target Therapeutics1988-08-19
THE BERG RESUSCITATION APPARATUS (K882833)Hursch Ent., Inc.1988-08-19
RESPIRONIC'S INFANT SECUREEASY (K882079)Respironics, Inc.1988-08-19
EXTERNAL PACEMAKER 2000 (EP2000) (K882168)Unomed, Inc.1988-08-19
DENTASCAN (K882906)Mpdi, Inc.1988-08-19
HR-2000 W/SUFFIXES B,C,D, CARDIO & DIGI LOOP, DDVP (K882175)Eigen1988-08-19
ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT (K880562)Macrochem Corp.1988-08-19
MECHANICAL TABLES AND ACCESSORIES (K882900)Rifton1988-08-19
SONICATOR 720 (MODEL ME720) (K883228)Mettler Electronics Corp.1988-08-18
CLIPPER POWER DRIVE WHEELCHAIR (K883339)Everest & Jennings, Inc.1988-08-18
THE VENUS SYSTEM (K880773)Neuroscientific Corp.1988-08-18
SWEDE ELITE, MECHANICAL WHEELCHAIR (K883275)Etac Us, Inc.1988-08-18
BUNN MODEL 50 OXYGEN FLOW CONTROLLER (K883216)The John Bunn Co.1988-08-18
ENDOVAGINAL PROBE, SMS-510VA (K882959)Toshiba Medical Systems1988-08-18
CANON AUTOREFRACTOMETER R-22 (K883200)Canon USA, Inc.1988-08-18
SAFECRIT PLASTIC MICROHEMATOCRIT TUBES (K883185)Norfolk Scientific, Inc.1988-08-18
SITE STERILIZATION TRAYS FOR OPHTHALMIC USE (K883098)Site Microsurgical Systems, Inc.1988-08-18
STORZ DISPOSABLE BIPOLAR PENCILS (K882802)Storz Instrument Co.1988-08-17
ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION (K883048)Alpha-Tec Systems, Inc.1988-08-17
PLATELIN(R) EXCEL L (K881999)Organon Teknika Corp.1988-08-17
SCEPTOR EXTEN. OF CONCENTRATION RANGE: PENCILLIN (K882911)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-08-17
SCEPTOR NEW ANTIMICROBIAL AGENT: IMIPENEM (K882912)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-08-17
DIMERTEST(R) LATEX (K882944)Agen Biomedical , Ltd.1988-08-17
SLT CONTACT LASER SYSTEM (K882212)Surgical Laser Technologies, Inc.1988-08-17
ATS PARA-SET CARBOL-XYLENE SOLUTION (K883061)Alpha-Tech Systems, Inc.1988-08-17
ATS PARA-SET IODINE ALCOHOL SOLUTION (K883049)Alpha-Tec Systems, Inc.1988-08-17
SCEPTOR NEW ANTIMICROBIAL AGENT: AMPICILLIN/SULBAC (K882910)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-08-17
STAR CALC (K875027)Infrasonics Corp.1988-08-16
PLEUR-EVAC-A-7000--ADULT/PEDI CHEST DRAINAGE SYST (K882223)Deknatel, Inc.1988-08-16
AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS (K882229)Biologics Intl., Inc.1988-08-16
LASER LARYNGOSCOPE DEDO ARTICULA. & FEDER DEDO EX (K882930)Pilling Co.1988-08-16
L-F/KODAK FLEXIBLE GRID CASSETTE (K883312)Mallinckrodt Group, Inc.1988-08-16
NONREBREATHING CIRCUIT (K882285)Dryden Corp.1988-08-16
RES-Q 1, 2, 3, 4 AND 5 (K881207)Nova-Ventrx1988-08-15
DONOR HORSE SERUM, CAT. NO. 110-1110 (K883291)J R Scientific1988-08-15
CMRL 1969 MAINTENANCE MEDIUM CAT, # 200-2177 (K883138)J R Scientific1988-08-15
FIXATION DEVICE, TRACH TUBE (K882694)Bioseal1988-08-15
TOMOSCAN LX COMPUTED TOMOGRAPHY SYSTEM (K882022)Philips Medical Systems, Inc.1988-08-15
RPMI-1640 W/25MM HEPES BUFF W/O SOD BICAR 200-2120 (K883141)J R Scientific1988-08-15
NEWBORN CALF SERUM, HEAT INACTIVATED # 110-1131 (K883286)J R Scientific1988-08-15
DONOR BOVINE SERUM, CAT. NO. 110-1116 (K883290)J R Scientific1988-08-15
MEDIUM 199 EBSS/NUTRIENT MIXTURE F-10 #200-2110 (K883139)J R Scientific1988-08-15
DIGITAL EMG MONITOR MYOTRON 120 (K882266)Ats Co.1988-08-15
O.R. SARACAP (K881002)Ppg/Applied Resources, Inc.1988-08-15
LUNG DIFFUSION GAS MIXTURE (K882817)Swisco, Inc.1988-08-15
CALF SERUM, GAMMA IRRADIATED, CAT. NO. 110-1126 (K883287)J R Scientific1988-08-15
CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES (K882488)Canyon Diagnostics, Inc.1988-08-15
DONOR HORSE SERUM, HEAT INACTIVATED, #110-1113 (K883288)J R Scientific1988-08-15
3 PHASE HIGH FREQ. DIAG. X-RAY GEN. MICRO-X 60HF (K880525)Fischer Imaging Corp.1988-08-15
FASTIDIOUS INOCULUM BROTH (K883075)Baxter Healthcare Corp1988-08-15
FETAL BOVINE SERUM, CAT. NO. 110-1120 (K883285)J R Scientific1988-08-15
MINIMUM ESSENTIAL MED (MEM,THERMO-POW(R)#200-2090 (K883140)J R Scientific1988-08-15
BOVINE SERUM, CAT. LNO. 110-1115 (K883292)J R Scientific1988-08-15
CT MAX 640 #B7940 JA/JE (K882581)General Electric Co.1988-08-15
CALF SERUM, HEAT INACTIVATED, CAT. # 110-1127 (K883289)J R Scientific1988-08-15
IDS RAPID ANA SYSTEM (K882960)Innovative Diagnostic Systems, Inc.1988-08-12
CILCO VILLASENOR PACHYMETER (K882805)Coopervision-Cilco1988-08-12
SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT (K874544)Molecular Biosystems, Inc.1988-08-12
PALLIAG NF III (K883036)Degussa Dental, Inc.1988-08-12
OVER THE NEEDLE CATHETER, ARTERIAL CATHETER NEEDLE (K882221)Argon Medical Corp.1988-08-12
SENTORR ARTERIAL PRESSURE SENSOR (K880830)Ohmeda Medical1988-08-12
EXTENDED SHELF LIFE FOR INTERSEPT* ARTERIAL 20/40 (K882137)Medtronic Blood Systems, Inc.1988-08-12
ASTRA DENTAL IMPLANT SYSTEM (K882578)Astra Meditec AB1988-08-12
PROFESSIONAL MODEL 7525 DELIVERY SYSTEM (K882759)Viadent1988-08-12
PROVIDER ONE INFUSION SYSTEM (K882102)Pancretec, Inc.1988-08-12
EASY-OP, PORTABLE DENTAL CART (K882810)Wy'East Medical Corp.1988-08-12
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Every clearance here is in the API, with alerts when new ones post.