Atlas FDA

1991

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

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RecordFirmDate
VENTREX COATED TUBE IGE RADIOIMMUNOASSAY (K905612)Ventrex Laboratories, Inc.1991-02-21
STERILE AND NON-STERILE TEXTILE PACKS (K904957)Surgical Pack Services, Inc.1991-02-21
CVIS INSIGHT IMAGING CATHETER (K905625)Cardiovascular Imaging Systems, Inc.1991-02-21
SURGICAL MASK (K905209)Lancaster County Blind Assoc.1991-02-21
EXTERNAL FIXATION (K904973)Dynasplint Systems, Inc.1991-02-21
TROCAR DISPOSABLE (K904638)L.A.S.E.R., Inc.1991-02-21
PACIFIC MARQUIS SPA (K910607)Marquis International , Ltd.1991-02-21
PLP LAPAROSCOPIC CHOLECYSTECTOMY DIS. ELEC. PROBES (K910184)Precision Laser Products, Inc.1991-02-21
PHARMACIA DELFIA NEONATAL HTSH KIT (K905710)Pharmacia, Inc.1991-02-21
LATERAL BUTTRESS SUPPORT (K905565)Mcconnell Orthopedic1991-02-21
NITRATE DISK (K905163)Remel Co.1991-02-20
RETIC-CHEX (K905524)Streck Laboratories, Inc.1991-02-20
INTHERM TEMPORARY OCCLUSION CATHETER (K901287)Interventional Therapeutics Corp.1991-02-20
MICRO-VENT ENDOSSEOUS IMPLANT ABUTMENTS (K900181)Core-Vent Corp.1991-02-20
DIA IMPRESSION COPING (K902435)Dental Imaging Assoc., Inc.1991-02-20
ASEPTIMINI UNIT, ADU-10 (K905401)Aseptico, Inc.1991-02-20
TORQUE HANDLE DEVICE FOR GUIDEWIRE (K905639)Lake Region Mfg., Inc.1991-02-20
MIDDLE EAR ANALYZER, MODEL AE-803 (K905213)American Electromedics Corp.1991-02-20
LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEM (K910038)Walter Lorenz Surgical, Inc.1991-02-20
PHILIPS BV-29 IMAGING SYSTEM (K910115)Philips Medical Systems, Inc.1991-02-20
SCREW-VENT ENDOSSEOUS IMPLANT ABUTMENTS (K900179)Core-Vent Corp.1991-02-20
STOMADENT TM (K905476)Dentsply Intl.1991-02-20
FST CATH-UD CATHETER (K905641)Fiberoptic Sensor Technlogies, Inc.1991-02-19
TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR (K904000)Armkel, LLC1991-02-19
LASERMATIC SUPERCOMBO(TM) SURGICAL LASER SYSTEM (K903131)Lasermatic, Inc.1991-02-19
CATALOG NUMBER 2609 LEG PLATE (K905295)Ge Medical Systems Information Technologies1991-02-19
NEW USCI 7F PTCA GUIDING CATHETER (K905249)C.R. Bard, Inc.1991-02-19
ITC BUNJI COIL (K900723)Interventional Therapeutics Corp.1991-02-19
VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLY (K904169)Varian Canada, Inc.1991-02-19
IONOBOND (K905724)Micro-Vac, Inc.1991-02-19
RICHARD-ALLAN SHEET CLIP (K905701)Richard-Allan Medical1991-02-19
ALGODERM ALGINATE WOUND DRESSING (K905314)Les Laboratorires Brothier, S.A.1991-02-19
SINGLE USE LAPARSCOPIC ELECTRODE (K904240)Aspen Labs1991-02-19
ZARA SOFT TIP CHIN IMPLANT (K910458)Byron Medical1991-02-19
IMMITTANCE METER, MODEL AE-105D/S (K905212)American Electromedics Corp.1991-02-19
ROMFLEX (K905718)Paraflex Corp.1991-02-19
ENDOCOAGULATOR KRS568(TM) LASER (K904700)Hgm Medical Laser Systems, Inc.1991-02-19
ZARA CHIN IMPLANT (K910456)Byron Medical1991-02-19
CONDOM (RUBBER) CONTRACEPTIVE (K905279)Aladan Corp.1991-02-19
THE DART (K905549)Dexide, Inc.1991-02-19
ZARA EXTENDED CHIN IMPLANT (K910457)Byron Medical1991-02-19
SANDBOX I, SANDBOX II, SANDBOX JR. (K903321)Sandbox Ent.1991-02-19
RICHARD-ALLAN CLAMP COVERS (K905682)Richard-Allan Medical1991-02-19
SILICONE COATED GUIDEWIRES (K905581)Lake Region Mfg., Inc.1991-02-19
MRP-7000(1) : 2-D INFLOW MR ANGIOGRAPHY (K905834)Summit World Trade Corp.1991-02-19
AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST (K904691)Air-Shields Vickers, Inc.1991-02-19
QUALTEX SURGICAL DRAPE (K910495)Deroyal Industries, Inc.1991-02-19
SOM 6V (K910357)Jedmed Instrument Co.1991-02-19
ACCUFLATE (K910512)Instrumed, Inc.1991-02-19
MRP-7000: SUPPLEMENTAL R/F COILS (K905835)Summit World Trade Corp.1991-02-19
DIGIFLEX, LATEX PATIENT EXAMINATION GLOVES (K910542)21st Century Group1991-02-19
AUTODERM SCANNER CONTROL CONSOLE (K904266)Charles I. Rose & Co., Inc.1991-02-19
HP MODEL M1008B, NONINVASIVE BLOOD PRESSURE MODULE (K903771)Hewlett-Packard Co.1991-02-19
CORE-VENT ENDOSSEOUS IMPLANT ABUTMENTS (K900180)Core-Vent Corp.1991-02-19
IRRIGATION CATHETER 4, 6 AND 10 FRENCH (K902256)Applied Vascular Devices, Inc.1991-02-15
CONDOMS (K905854)Barnetts, Inc.1991-02-15
ISOLA(TM) SPINE SYSTEM TOP ENTRY HOOK (K905184)Acromed Corp.1991-02-15
MULTI-LUMEN CENTRAL VENOUS CATHETER SET (K904404)Arrow Intl., Inc.1991-02-15
ULTRACISION HARMONIC SCALPEL (K905315)Ultracision, Inc.1991-02-15
PERIO PIK (K905188)Teledyne Water Pik1991-02-15
OCHSNER 50 VASCULAR PROSTHESIS (K905270)Intervascular, Inc.1991-02-15
GERI TOTAL HIP SYSTEM (K905186)Smith & Nephew Richards, Inc.1991-02-15
TRAVELER, MOTORIZED THREE-WHEELED VEHICLE (K910265)Pillar Technology, Inc.1991-02-14
CYBEX 6000 (K905525)Cybex1991-02-14
TENONE(TM) METHAMPHETAMINE (K910043)Diagnostic Products Corp.1991-02-14
MEDTRONIC (R) MODEL 3625 SCREENER (K903690)Medtronic Vascular1991-02-14
MYOCARDIAL TEMPERATURE MONITORING PROBES, CJ-1000 (K905652)Daily Medical Products, Inc.1991-02-14
FIBRINOTEST(TM) - FIBRINOGEN ASSAY (K903874)Haemachem, Inc.1991-02-14
IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTOR (K910455)Ziehm International, Inc.1991-02-14
DATA RECORDER (K910118)Healthdyne, Inc.1991-02-14
EYE SEE INSTRUMENT (K905237)King Tool, Inc.1991-02-14
KINETIC ALKALINE PHOSPHATASE DETERMINATION (K905650)Biochemical Trade, Inc.1991-02-13
VPW2877E7 X RAY POWER SUPPLY (K905855)Varian Canada, Inc.1991-02-13
K-MODULE II HEAT THERAPY SYSTEM (K910061)Baxter Healthcare Corp1991-02-13
STRATUS ESTRADIOL FLUOREMETRIC ENZYME (K910249)Baxter Healthcare Corp1991-02-13
TUBE DECLOGGER (K905164)Nova Design Technologies, Ltd.1991-02-13
WHITESIDE ORTHOLOC MODULAR TIBIAL CONSTRAIN.INSERT (K905076)Dow Corning Wright1991-02-13
PRIMARY MANUFACTURER SUNGLASSES (K903065)Mao Lin Ent.1991-02-13
7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815) (K902728)Ausonics Pty , Ltd.1991-02-13
CLEARBLUE EASY (K905742)Unipath , Ltd.1991-02-13
HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECES (K905155)Star Dental Mfg. Co.1991-02-13
CHILDREN SUNGLASSES (K910141)Consolidated Stores Intl. Corp.1991-02-13
CREATININE (RATE) REAGENT SET (K905619)Biochemical Trade, Inc.1991-02-13
G.E. DXD 325/350/350II/DXD 525/525II GENERATORS (K902986)Electromek Diagnostic Systems, Inc.1991-02-13
AVD INTIMAX (TM) BILIARY CATHETER (K910006)Applied Vascular1991-02-13
MILENIA COCAINE METABOLITE (K910044)Diagnostic Products Corp.1991-02-13
BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERS (K905707)Baxter Healthcare Corp1991-02-13
OLYMPUS URINE PH CALIBRATORS LEVELS I AND II (K905477)Em Diagnostic Systems, Inc.1991-02-13
AVALON GENERAL PURPOSE SCANNER, PREVIEW GP (K904317)Avalon Technology Corp.1991-02-13
BONE PAD REMOVER (K910225)Acra Cut, Inc.1991-02-12
PATIENT EXAM GLOVES(MFG: YUNG CHIEH ENTERPRISE) (K904839)Up TO Date, Inc.1991-02-12
EXIT ALARM (K905421)Alertcare1991-02-12
COBE CENTRY 2 BICART OPTION KIT (K905793)Cobe Laboratories, Inc.1991-02-12
DURAL DISSECTORS (K910226)Acra Cut, Inc.1991-02-12
SAFE-SITE NEEDLE COVER (K905305)North American Medical Products, Inc.1991-02-12
FLEXCOMP DSP & PROCOMP (K903497)Thought Technology , Ltd.1991-02-12
APOLLO MOBILE SCALE (K905061)Apollo Enterprise, Ltd. Co.1991-02-12
#504 MINI COMPRESSOR (K904045)Medical Industries America, Inc.1991-02-12
PATIENT EXAMINATION GLOVES (K910442)Asian Latex, Ltd.1991-02-12
MAXI ASPIRATOR (K902184)Medical Industries America, Inc.1991-02-12
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Track 1991 automatically

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