Atlas FDA

1991

4,235 FDA 510(k) clearances · Clearance year

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RecordFirmDate
VARIOUS TYPES OF STETHOSCOPES (K905487)Liaoning-Usa Corp.1991-04-09
TEGWIRE (TM) (K911203)Boston Scientific Corp1991-04-09
FORMASURE TEST REAGENT (K905217)Di-Chem, Inc.1991-04-09
MODEL FT40 TRANSONIC(TM) HEARING AID (K905516)Sonovation, Inc. Dba Avr Sonovation1991-04-09
VAS-CATH URETERAL STENTS CATHETER, MODIFICATION (K905505)Vas-Cath, Inc.1991-04-09
USCI ILLUMEN-8 8F PTCA GUIDING CATHETER (K910154)C.R. Bard, Inc.1991-04-09
FELDMUEHLE CERAMIC HEAD (12/14 X 32MM) (K910548)Turnkey Intergration USA, Inc.1991-04-09
OPTILITE (TM) FIBEROPTIC DELIVERY SYSTEMS AND ACCE (K910114)Xintec Corporation1991-04-09
3M LASER IMAGER XL (K910092)3M Medical Products Group1991-04-08
TRACHEOSTOMY CARE KIT (K910362)Megadyne Medical Products, Inc.1991-04-08
LIFE PT VASC ACCESS PT W/DETACH CATH(LPS 6013)MODI (K905848)Strato Medical Corp.1991-04-08
EPIDURAL INDICATION FOR VOLUMETRIC INFUSION PUMPS (K910428)Baxter Healthcare Corp1991-04-08
MODEL RFG-3C RADIOFREQUENCY LESION GENERATOR (K901540)Radionics, Inc.1991-04-08
LAPAROMED CHOLANGIOGRAM DEVICE (K910219)Laparomed Corp.1991-04-08
CAPINTEC THYROID UPTAKE SYSTEM-VARIOUS MODELS (K910020)Capintec Instruments, Inc.1991-04-08
SCITECH BI-MANUAL ADAPTER CLIPS (K910088)Scitech Industries Partnership1991-04-08
SHARPLAN ND:YAG SURG LASER, 3065, SHARPLASER 65 (K910051)Sharplan Lasers, Inc.1991-04-08
DISPOSABLE FIBER OPTIC DELIVERY SYSTEM (K904420)Fiber Delivery Concepts, Inc.1991-04-08
ENZYMUN-TEST PROGESTERONE (K910683)Boehringer Mannheim Corp.1991-04-08
10 ADJUSTABLE BELT COIL (K910269)Resonex, Inc.1991-04-08
PROBE SURGEON'S GLOVES- STERILE (K905624)Glove India Pvt. , Ltd.1991-04-08
LAPAROMED CHOLANGIOGRAM VACUUM DEVICE (K910218)Laparomed Corp.1991-04-08
PLP LAPAROSCOPIC CHOLECYSTECTOMY SET (K910137)Precision Laser Products, Inc.1991-04-08
STRATO LOW PROFILE PORT(LPS 1055)/MODIFICATION (K905846)Strato Medical Corp.1991-04-08
OSTEONICS(R) MID-SHAFT CEMENT SPACER (K910461)Osteonics Corp.1991-04-08
SYNCHRON LACTATE REAGENT (K910534)Beckman Instruments, Inc.1991-04-08
EQUIPMENT/MATERIAL DECONTAMINATING KIT (K911299)Rohm and Haas Co.1991-04-08
CMS ONCOPROBE (TM) (K904421)Cryomedical Sciences, Inc.1991-04-08
PORT-OF-ORGIN(TM) SINGLE-USE TROCAR AND SLEEVE (K904848)Origin Medsystems, Inc.1991-04-08
MICROSURGICAL INSTRUMENTS (K911300)Danek Medical, Inc.1991-04-05
PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.K (K910315)Sorex Medical1991-04-05
MICROLINE SCREEN FOR METHAMPHETAMINE (K910525)Drug Screening Systems, Inc.1991-04-05
NA ALPHA 1 MICROGLOBULIN KIT (K904254)Behring Diagnostics, Inc.1991-04-05
ABUSCREEN ONTRAK FOR BENZODIAZEPINE (K910590)Roche Diagnostic Systems, Inc.1991-04-05
SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOM (K905459)Angiosystems, Inc.1991-04-05
OSTEONICS CDH HIP STEM (K910922)Osteonics Corp.1991-04-05
SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE) (K911175)Serono-Baker Diagnostics, Inc.1991-04-05
DERMATEK 4000 (K911057)Anacom General Corp.1991-04-05
STRATO LIFE PORT II DUAL LUMEN PORT/MODIFICATION (K905847)Strato Medical Corp.1991-04-05
PROBET (TM) (K903002)Gynopharma, Inc.1991-04-05
STRATO PLAST W/PRE-ATTACH CATH(LPS 6015)/MODIFIED (K905851)Strato Medical Corp.1991-04-05
RHEUMAJET RF (K910539)Biokit USA, Inc.1991-04-05
MAST CLA ALLERGY SYSTEM (K910292)Mast Immunosystems1991-04-05
SURG TECH,INC. 30 GAUGE STRAIGHT EXTRUSION NEEDLES (K910036)Surgical Technologies, Inc.1991-04-04
TARGET(TM) CANNABINOIDS-V TEST (K910892)V-Tech, Inc.1991-04-03
DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD (K911056)E.I. Dupont DE Nemours & Co., Inc.1991-04-03
ORTH-EVAC(TM) SUCTION HAND BULB MODEL NO. 01-150 (K910211)Deknatel, Inc.1991-04-03
SYNCHRON CX4, CX5, AND CX7 CLINICAL ANALYZER (K910185)Beckman Instruments, Inc.1991-04-03
IL PHENOBARBITAL ASSAY SYSTEM (K910355)Instrumentation Laboratory CO1991-04-03
IL THEOPHYLLINE ASSAY SYSTEM (K910697)Instrumentation Laboratory CO1991-04-03
ABUSCREEN FP FOR CANNABINOIDS (50-100) (K910589)Roche Diagnostic Systems, Inc.1991-04-03
FLOW CYTOMETRY FITC/PE COMPENSATION KIT (K910255)Sigma Diagnostics, Inc.1991-04-03
VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION (K910666)Vitek Systems, Inc.1991-04-03
CIBA CORNING ACS CKMB IMMUNOASSAY (K911121)Ciba Corning Diagnostics Corp.1991-04-03
RESORBABLE BONE PLUG (K905740)Zimmer, Inc.1991-04-03
STRATO STAND METAL PORTS (LPS 1013/1015)/MODIFIED (K905844)Strato Medical Corp.1991-04-03
MCLAUGHLIN LAPAROSCOPIC GRASPER (K910578)Marlo Surgical Technology1991-04-03
TEETHMATE-F (K910424)Kuraray Co.1991-04-03
GLUCOSE V (K910573)Caro Med, Inc.1991-04-03
TARGET(TM) CANNABINOIDS-R TEST (K910893)V-Tech, Inc.1991-04-03
RESPIRONICS' DIGITAL MANOMETER (K904935)Respironics, Inc.1991-04-03
MX4043---SERIES, INTRAUTERINE PRESSURE CATHETER (K910227)Medex, Inc.1991-04-03
VENAPULSE MODELS VP-25 AND VP-50 (K903894)Aci Medical, Inc.1991-04-03
COOLING TEETHERS (K902974)Realgrow Intl. Corp.1991-04-03
ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINE(500 NG/ML) (K910278)Roche Diagnostic Systems, Inc.1991-04-03
ABUSCREEN ONTRAK FOR METHAMPHETAMINE (K910658)Roche Diagnostic Systems, Inc.1991-04-03
DIAL-AWAY PAIN (K904457)R.F.P., Inc.1991-04-03
LYPHOCHEK BENZO/TCA CONTROL SERUM, LEVELS 1 AND 2 (K910829)Bio-Rad1991-04-03
ELECTONE ITE MODEL PREMIER (K910097)Electone, Inc.1991-04-03
DENTAURUM CERAMIC DEBONDING UNIT (K902018)Dentauraum, Inc.1991-04-03
MICROZYME TSH ENZYME IMMUNOASSAY KIT (K910411)Immunotech Corp.1991-04-03
CYTOMEGALOVIRUS (CMV) ELISA (K904456)Virotech, Inc.1991-04-03
GEM-PREMIER SYSTEM (K910305)Mallinckrodt Sensor Systems, Inc.1991-04-03
RADIOGRAPHIC/FLUOROSCOPIC TABLE MODEL 9004 (K911267)Tri W-G, Inc.1991-04-03
OCHSNER 500 VASCULAR PROSTHESIS (K905269)Intervascular, Inc.1991-04-02
AUTOGENESIS(TM) AUTOMATOR (K905514)Advanced Biosearch Assn.1991-04-02
BIVONA ENDOTRACHEAL TUBE STYLET (K905052)Bivona Medical Technologies1991-04-02
MINIPRO 8100 URODYNAMIC MEASUREING SYSTEM (K910217)Browne Medical Systems, Inc.1991-04-02
BROWNE MEDICAL SYST.INC STAND-ALONE WATER PUMP (K910285)Browne Medical Systems, Inc.1991-04-02
MMG/O'NEIL URINARY CATHETERIZATION SYSTEM KIT (K910022)Medical Marketing Group1991-04-02
SERIM GLUTARALDEHYDE/NEPHREX POTENCY TEST KIT (K902227)Serim Research Corp.1991-04-02
HEXIDIS ALCOHOL SWAB (K910735)Specialites Septodont1991-04-02
SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M (K910783)Smith & Nephew Equipment Group1991-04-02
BILIARY BALLOON DILATATION CATHETER (K910931)Boston Scientific Corp1991-04-02
MEDIFIL (K910944)Biocore1991-04-02
CANNULA INTRODUCTION SET (K910015)Lazarus Medical, Inc.1991-04-02
WILSON COOK WIRE GUIDE AND PROTECTIVE GUIDE (K910497)Wilson-Cook Medical, Inc.1991-04-02
CONDOR ANALOG INFLATION SYRINGE (K904508)Professional Medical Services1991-04-02
NORMLGEL PROTECTIVE WOUND GEL (K905438)Scott Health Care1991-04-01
RSVP RF-2000 (K905586)Tactilitics, Inc.1991-04-01
WEEVAC TC HAND CARRIED RESCUE STRETCHER (K910709)W. Murphy Ent., Inc.1991-04-01
BLADES FOR SPINAL LAMINECTOMY RETRACTOR (K910621)International Hospital Supply Co.1991-04-01
CLEANFLOW SYSTEM (K910728)Mitron Technologies, Inc.1991-04-01
PRECISE FLEXISTAPLER CIRCULAR STAPLER, SERIES 398X (K910897)3M Medical Products Group1991-04-01
KELLER VITAL SIGNS MONITOR - KMS-890 (K910262)Keller Medical Specialties Products, Inc.1991-04-01
KINEMAX SUPERSTABILIZER TOTAL KNEE SYSTEM (K904208)Howmedica Corp.1991-04-01
CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETS (K910906)Tri-State Hospital Supply Corp.1991-04-01
BAXTER MARATHON(R) INTRAVASCULAR GUIDING CATHETERS (K910208)Baxter Healthcare Corp1991-04-01
GOOD VIBRATIONS TUBE MASSAGER (K910519)Dual Voltage, Inc.1991-04-01
CUTINOVA HYDRO (K905688)Beiersdorf, Inc.1991-04-01
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Track 1991 automatically

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