Atlas FDA

1991

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

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RecordFirmDate
SYVA EDMS (K912055)Syva Co.1991-06-10
DADE LIID-TROL TL TRI-LEVEL LIPID CONTROL (K911854)Baxter Healthcare Corp1991-06-10
MYOCARDIAL PROTECTION SYSTEM (K905500)Medtronic Vascular1991-06-10
BROWNE MEDICAL SYSTEMS IMAGEPRO (K910444)Browne Medical Systems, Inc.1991-06-10
COROMETRICS 5566AAX NONINVASIVE BLOOD PRESSURE MOD (K911310)Ge Medical Systems Information Technologies1991-06-10
SCHNEIDER TOTAL CROSS .021 PERCU TRANS ANGIO (PTA) (K911196)Schneider Intl., Ltd.1991-06-10
PALCO LABS MODEL 300 OXYGEN/PULSE MONITOR (K911191)Palco Laboratories, Inc.1991-06-10
NICOLET MAPLELEAF SYSTEM (K905632)Nicolet Instrument Corp.1991-06-07
HYDROXYAPATITE COATED PROFILE(R) HIP STEM (K910156)Depuy, Inc.1991-06-07
COMPULSE CO2 SURGICAL LASER SYS. (K911852)Laser Engineering, Inc.1991-06-07
503 PULSE OXIMETER (K911124)Criticare Systems, Inc.1991-06-07
OP-D-OP VISOR SHIELDS (K911742)Op-D-Op, Inc.1991-06-07
KODAK 100-J & 100-K CHEMICAL MIXERS (K911713)Eastman Kodak Company1991-06-07
DEGULUX LIGHT CURING UNIT (K912037)Degussa AG1991-06-07
VISTA HPQ SYSTEM (K910715)Philips Medical Systems (Cleveland), Inc.1991-06-07
KODAK M35-MX-0MAT PROCESSOR (K911714)Eastman Kodak Company1991-06-07
LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITS (K904440)Preferred Medical Products1991-06-07
KODAK AUTOMATIC FILM FEEDER, MODEL RA (K911711)Eastman Kodak Company1991-06-07
PHILIPS M30 IN-THE-EAR HEARING AID (K912339)Philips Hearing Instruments Co.1991-06-07
ISOTECHNOLOGIES LIFTSTATION & LIFTWORKS SOFTWARE (K912175)Isotechnologies, Inc.1991-06-07
ELITE SYSTEM (K911416)Gfb Intl. Trading, Inc.1991-06-06
EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUG (K905427)Eagle Vision, Inc.1991-06-06
COMFOR-BOARD (K910880)Medway1991-06-06
MY-O-MATIC 5000I (K902226)Monad Corp.1991-06-06
STEREOTACTIC IRRADIATION SYSTEM (K904908)Northwest Medical Physics Center1991-06-06
MODEL M1251A MON. FULL DISCLOSURE REVIEW SYSTEM (K905788)Hewlett-Packard Co.1991-06-06
PALAVIT GLC (K904928)Kulzer, Inc.1991-06-06
SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT (K910426)Shimadzu Medical Systems1991-06-06
ORIGINALS (K911277)Face 2 Face Corp.1991-06-06
THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2 (K911246)The Medical Group, Inc.1991-06-06
INLAY 90 (K911546)Metalor Dental USA Corp.1991-06-06
I.V. EXTENDER SET (K911451)Filtertek, Inc.1991-06-06
PROBE REFILL KIT (K911073)Interspec, Inc.1991-06-06
PERFOURM PUTTY SOFT (K910189)Heraeus Kulzer, Inc.1991-06-06
VITAPATCH PIN PROTECTION DEVICE FOR PERCUTANEOUS (K895920)Vitaphore Corp.1991-06-06
SELECTOR MD (50KW AND 80 KW) (K910650)Hofmann-Nagel Medical Systems, Inc.1991-06-06
CUTTERSIL MUCOSA (K910165)Heraeus Kulzer, Inc.1991-06-06
GESCO PER-Q-CATH NEEDLE (K911215)Gesco Intl., Inc.1991-06-06
CUTTERSIL XL (K910166)Heraeus Kulzer, Inc.1991-06-06
MENSOR COMPLIANT KEEPER (K885158)Merrill C. Mensor, Jr., D.D.S.1991-06-06
HYDENT (K911259)Pascal Co., Inc.1991-06-06
NEW TRIAD VLC CROWN & BRIDGE PROVISIONAL MATERIAL (K904251)Dentifax Intern, Inc.1991-06-06
MELIODENT, DENTURE RESIN (K910465)Heraeus Kulzer, Inc.1991-06-06
CUTTERSIL FUNCTION ACTIVATOR (K910360)Heraeus Kulzer, Inc.1991-06-06
MEDISYSTEMS ANTI-STICK INJECTION SITE NEEDLE (K910733)Medisystems Corp.1991-06-06
PALAVIT L (K905058)Kulzer, Inc.1991-06-06
NEEDLE, ASPIRATION & INJECTION, DISPOSABLE (K902422)Gainor Medical Europe, Ltd.1991-06-06
CINEMEASURE (TM) (K910654)Syracuse Research Corp.1991-06-06
HEMOSTATIC Y CONNECTOR (K911130)Thomas Medical Products, Inc.1991-06-06
VACUUM-ASSISTED BLOOD COLLECTION SYSTEM (K905818)Jtl Medical Corp.1991-06-06
LAPAROSCOPIC RINSING CONTAINER (K911488)United States Endoscopy Group, Inc.1991-06-06
MARK 5 ROBOTIC PIPETTOR (K912228)Diagnostic Products Corp.1991-06-06
OSTEONICS ION IMPLANTED TOTAL KNEE FEMORAL COMP (K910989)Osteonics Corp.1991-06-05
ELECTRO-NERVE STIMULATOR TENS MODEL BIOMED 2000/A (K905570)Biomedical Life Systems, Inc.1991-06-04
4' LOW VOLUME IV EXTENSION SET (K905219)Marquette Medical, Inc.1991-06-04
POINTER F-3 TENS (K904388)Oms Medical Supplies, Inc.1991-06-04
NEUROSEARCH-24 OR NRS-24 (K904269)Lexicor Medical Technology, Inc.1991-06-04
4 LOW VOLUME IV EXTENSION SET WITH SLIDE CLAMP (K905218)Marquette Medical, Inc.1991-06-04
PALMAZ(TM) BALLOON-EXPANDABLE STENT, MODIFICATION (K911581)Johnson & Johnson Interventional Systems1991-06-04
LITHOTRIPTOR SYSTEM MODEL 27080 (K905553)Karl Storz GmbH & Co. (Kst)1991-06-04
INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE (K911041)Invotec International, Inc.1991-06-04
ELECTRO-NERVE STIMULATOR TENS MODEL SYSTEMS 2000/A (K905377)Biomedical Life Systems, Inc.1991-06-04
CONDOMS (RUBBER CONTRACEPTIVES) (K910284)Suretex, Ltd.1991-06-04
ELECTRO-NEVE STIMULATOR TENS MODEL BIOMED PLUS/A (K905230)Biomedical Life Systems, Inc.1991-06-04
CROSSFIRE LASER ASSISTED ASPIRATION CANNULA (K911408)Heraeus Lasersonics, Inc.1991-06-03
INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER (K911840)Intec Medical, Inc.1991-06-03
VERSACATH(TM) MULTILUMEN SYSTEM (K910566)Menlo Care, Inc.1991-06-03
STABIDENT LOCAL ANESTHESIA SYSTEM (K910446)Fairfax Dental, Inc.1991-06-03
NORCATH VASCULAR ACCESS CATHETERS (K911067)Norfolk Medical1991-06-03
RATEMINDER(TM) V INFUSION PUMP, MODIFICATION (K911769)Critikon Company, LLC1991-06-03
CIRCON ACMI HYDROLAPAROSCOPE(TM) INSTRUMENT (K911053)Circon Video1991-06-03
VERSACATH(TM) SELECTALUMEN(TM) W/CONVERSION TRAY (K910565)Menlo Care, Inc.1991-06-03
SYNERMED UREA NITROGEN REAGENT KIT (K911248)Synermed, Inc.1991-06-03
CHARISMA (K910263)Kulzer, Inc.1991-06-03
CONDOMS/SAXON, GOLD CIRCLE COIN, EMBRACE & RAINBOW (K910550)Safetex Corp.1991-06-03
DASH MEDICAL GLOVES (K912038)Safehealth Labs1991-06-03
SPENCIO SKIN GUARD KIT (K910927)Spenco Medical Corp.1991-06-03
INVOTEC MICROSCOPE DRAPE (K911040)Invotec International, Inc.1991-06-03
ACA(R) URINE PHENCYCLIDINE (U PCP) SCREEN METHOD (K911725)E.I. Dupont DE Nemours & Co., Inc.1991-06-03
IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP/ACCESS (K911163)Imagyn Medical, Inc.1991-06-03
OLYMPUS ANGIOSCOPY IRRIGATION SHEATH (K910933)Olympus Corp.1991-06-03
NASCOR OXYDOME (K905627)Nascor Pty. , Ltd.1991-06-03
TRUMPET VALVE (K911415)B. Braun of America, Inc.1991-06-03
NEV-10 NEGATIVE PRESSURE VENTILATOR (K910947)Lifecare Services, Inc.1991-06-03
RAMP RAT (K911986)Vehicle Dynamics1991-05-31
MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLING (K905464)Angiosystems, Inc.1991-05-31
DIRECTIGEN 1-2-3 PREGNANCY CONTROLS (K911664)Quidel Corp.1991-05-31
T600 TREADMILL (K910867)Siemens Burdick, Inc.1991-05-31
VIBROMETRY SYSTEM (K901881)Bruel & Kjaer Instruments, Inc.1991-05-31
RHEUMAGEN RF T-CONTROL (K904310)Biokit USA, Inc.1991-05-31
SPLINTER TWEEZERS (K910570)Solan Scissors Sales1991-05-31
JAIN SUTURE PACKAGE COUNTER (K911077)Jain Surgical Equipment, Inc.1991-05-31
INFUSION PUMP (K910844)Technology Transfer Intl., Inc.1991-05-31
ENDOPATH SURGICAL INSTRUMENTS (K910831)Symbiosis Corp.1991-05-31
VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT. (K904813)Alpha-Dent1991-05-31
IV EXTENSION SETS WITH .22 MICRON FILTER (K905374)Marquette Medical, Inc.1991-05-31
VOLUMETRIC INFUSION PUMP (K910024)Baxter Healthcare Corp1991-05-31
ERA 2000A (K911261)Neotronics, Inc.1991-05-31
SURGICA(TM) H (K910898)Hgm Medical Laser Systems, Inc.1991-05-31
HITACHI MRP-7000 MAGNETIC ROSONANCE DEVICE (K911667)Hitachi Medical Systems America, Inc.1991-05-30
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Every clearance here is in the API, with alerts when new ones post.