Atlas FDA

1991

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

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RecordFirmDate
APPLICATOR LOOP SUTURES (K911157)Northgate Technologies, Inc.1991-04-25
AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS (K910214)American Medical Corp.1991-04-25
STANDARD RUBBER DAM WITH OR WITHOUT FRAMES (K905470)Elastomade Accessories Sdn Bhd1991-04-25
PHARMACIA SPECIFIC IGE CONTROL (K911631)Pharmacia, Inc.1991-04-24
ROCHE REAGENT FOR DIRECT BILIRUBIN (K910593)Roche Diagnostic Systems, Inc.1991-04-24
MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT (K904538)Mauna Loa Medical, Inc.1991-04-24
ACID CONCENTRATE SOLUTIONS (K910319)Biopharm, Inc.1991-04-24
BAG SPIGOT (K910673)Procedure Products, Inc.1991-04-24
FUJI COMPUTED RADIOGRAPHY SYSTEM FCR 7501 (K910437)Fujifilm Medical System U.S.A., Inc.1991-04-24
ROCHE REAGENT FOR TOTAL BILIRUBIN (K910591)Roche Diagnostic Systems, Inc.1991-04-24
GRADUATED CYLINDER OF EXTERNAL DRAINAGE SET (K910853)Cordis Corp.1991-04-24
SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM) (K910204)Baxter Healthcare Corp1991-04-24
NOVOSTE GUIDING CATHETER (K911527)Novoste Corp.1991-04-24
ANESTHESIA CONDUCTION FILTER (K902666)Arbor Technologies, Inc.1991-04-23
GRANSTAND (K911608)Prime Engineering1991-04-23
GE QUADRATURE CERVICAL SPINE SURF COIL, M1285AR (K910817)General Electric Co.1991-04-23
KODAK EKTASCAN DIGITAL INTERFACE/FOR AT&T (K911405)Eastman Kodak Company1991-04-23
LAPAROSCOPIC SUCTION IRRIGATION TUBING SET (K911484)United States Endoscopy Group, Inc.1991-04-23
CCI CORNEAL SCARIFIER (K904505)Buckman Co., Inc.1991-04-23
SLEEPAP (K905593)Medical Industries America, Inc.1991-04-23
D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEM (K904599)Digital Design, Inc.1991-04-23
TEMPERATURE WELL PROBE, TWP SERIES (K910868)Gish Biomedical, Inc.1991-04-22
STYLET TRACHAEL TUBE (K905133)Medical Devices, Inc.1991-04-22
LAPAROSCOPIC SNARE (K911482)United States Endoscopy Group, Inc.1991-04-22
ANTIMICROBIAL GENTAMICIN (K911305)Alamar Biosciences Laboratory, Inc.1991-04-22
GOWN, OPERATING SURGICAL (K911568)Huntsville Rehabilitation Foundation1991-04-22
I/A HANDPIECE WITH REPLACEABLE TIPS (K910245)Surgical Technologies, Inc.1991-04-22
FORTRESS 1600ACV REAR WHEEL DRIVE SCOOTER (K910751)Fortress Litestyle1991-04-22
PRESSURE MONITORING EXTENSION LINE (K910378)Professional Medical Services1991-04-22
HERAEUS LASERSONIC, INC STERILE DISPOSABLE FIBERS (K910894)Heraeus Lasersonics, Inc.1991-04-22
ANTIMICROBIAL TOBRAMYCIN (K911304)Alamar Biosciences Laboratory, Inc.1991-04-22
MODIFICATION TO MODEL 90-1460 LASER ADAPTER (K911523)Lifestream Int'L, Inc.1991-04-22
MD CO2 SURGICAL LASER SYSTEM/GEN. SURGERY AND ORTH (K905676)Laser Engineering, Inc.1991-04-22
FORTRESS MODEL SPIRIT 4-WHEEL POWER WHEELCHAIR (K910753)Fortress Litestyle1991-04-22
ANTIMICROBIAL SUSCEPT. TEST PANEL TICARC./CLAVUL. (K911556)Alamar Biosciences Laboratory, Inc.1991-04-22
ANITIMICROBIAL SUSCEPT. TEST PANEL AMOX./CLAVUL. (K911555)Alamar Biosciences Laboratory, Inc.1991-04-22
ANTIMICROBIAL SUSCEPT. TEST PANEL TICARCILLIN (K911557)Alamar Biosciences Laboratory, Inc.1991-04-22
MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST (K904832)Hewlett-Packard Co.1991-04-22
SURGICAL TROCAR (K911462)Applied Medical1991-04-22
RESTING EKG ELECTRODE SERIES (K910494)Medtronic Andover Medical, Inc.1991-04-22
X-T AIR DRILL (K905800)Xomed-Treace, Inc.1991-04-22
MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION (K910291)Hewlett-Packard Co.1991-04-22
ANTIMICROBIAL SUSCEPT. TEST PANEL CEFONICID (K911559)Alamar Biosciences Laboratory, Inc.1991-04-22
THE PERCEPTOR(TM) STAND ALONE TRANSDUCER (K910764)North American Instrument Corp.1991-04-22
VALLEY FORGE BIPOLAR PEN OR FORCEPS (K910510)Valley Forge Scientific Corp.1991-04-22
ANTIMICROBIAL AMPICILLIN (K911185)Alamar Biosciences Laboratory, Inc.1991-04-22
INTERMEDICS MODEL 431-11 IMPLANT ENDOCARD PAC LEAD (K903948)Intermedics, Inc.1991-04-22
FORTRESS MODEL 760-V 4 WHEEL POWER WHEELCHAIR (K910749)Fortress Litestyle1991-04-22
LAPAROSCOPIC CLEANING BRUSH INSTRUMENT (K911481)United States Endoscopy Group, Inc.1991-04-22
CUSTOM PERSONAL EAR - CPE (K911497)Qualitone1991-04-19
STRATO PLASTIC PORT INTRO KT(10 FR) LPS 7523/MODIF (K905849)Strato Medical Corp.1991-04-19
STRATO PORT INTRODUCER KT(9 FR) LPS 5513/MODIFIED (K905845)Strato Medical Corp.1991-04-19
STRATO PORT INTRODUCER KT(10 FR) LPS 5015/MODIFIED (K905838)Strato Medical Corp.1991-04-19
ULTRA & ULTRA LITE II, MODIFICATION (K911504)Qualitone1991-04-19
AXOSTIM NERVE STIMULATOR, MODIFICATION (K905035)Singer Medical Products, Inc.1991-04-19
ADJUSTRETTE - DAO, MODIFICATION (K911498)Qualitone1991-04-19
STORZ ULTRA-SOURCE HIGH OUTPUT ILLUMINATOR (K904616)Storz Instrument Co.1991-04-19
JENSEN III CHIROPRACTIC J-TABLE (K905647)Freedman, Wolk and Co.1991-04-19
MOSS GASTROSTOMY TUBE (K910913)Moss Medical Products1991-04-19
STRATO PORT INTRODUCER KT(12 FR) LPS 5200/MODIFIED (K905841)Strato Medical Corp.1991-04-19
ULTRA-SELECT PTCA GUIDEWIRE (K910280)Microvena Corp.1991-04-19
ICT-1108 IMPLANT- THREADED (CEMENT TYPE ABUTMENT) (K903043)Minimatic Implant Technology1991-04-19
STRATO PLASTIC PORT INTRO(9 FR)LPS 7513/MODIFIED (K905850)Strato Medical Corp.1991-04-19
STRATO PORT INTRODUCER KT(10 FR) LPS 5013/MODIFIED (K905839)Strato Medical Corp.1991-04-19
STRATO PORT INTRODUCER KT(10 FR) LPS 5057/MODIFIED (K905840)Strato Medical Corp.1991-04-19
COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM (K910377)CooperSurgical, Inc.1991-04-19
ELEGANCE - DEO, MODIFICATION (K911499)Qualitone1991-04-19
8 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER (K910486)Davol, Inc.1991-04-19
FORCEPS, COAGULATION, BIPOLAR, MALIS (K911377)International Hospital Supply Co.1991-04-19
LPI YAG MODEL 1003 SURGICAL LASER SYST/MODIFIED (K904841)Laser Photonics, Inc.1991-04-19
IDT-1104 IMPLANT (SCREW-IN-THREADED) (K903046)Minimatic Implant Technology1991-04-19
STRATO PLAST PORT INTRO KT(10 FR)LPS 7013/MODIFIED (K905852)Strato Medical Corp.1991-04-19
ARGYLE POLYURETHANE SALEM SUMP TUBE (K910479)Sherwood Medical Co.1991-04-19
STRATO PORT INTRODUCER KT(12 FR) LPS 5213/MODIFIED (K905842)Strato Medical Corp.1991-04-19
BARD PCA II PUMP WITH PROGRAM CARTRIDGES (K902613)C.R. Bard, Inc.1991-04-19
STRATO PLAST INTRODUCER KIT(12 FR) LPS 7113/MODIF (K905843)Strato Medical Corp.1991-04-19
A-PORT IMPLANT VASC ACCESS SYST LINE EXT-A2 PORT (K911055)Therex Corp.1991-04-19
PATHWAY II ELECTROMYOGRAPH (K897132)The Prometheus Group1991-04-18
PLANMED SOPHIE (K904953)Planmeca USA, Inc.1991-04-18
IPV PERCUSSIONATOR FAMILY & RELATED ACCESSORIES (K905236)Percussionaire Corp.1991-04-18
VARIOUS TEMPLATE APPLICATORS (K910862)Best Industries1991-04-18
ENDOPATH VERESS NEEDLE (K910855)Symbiosis Corp.1991-04-18
MODEL 5857-3M LEAD END CAP KIT (K911048)Medtronic Vascular1991-04-18
PREMIXED DIALYSATE FOR HEMODIAFILTRATION (K910270)Baxter Healthcare Corp1991-04-18
DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM) (K910254)CooperSurgical, Inc.1991-04-18
URESIL VALVE CUTTER (K905528)Uresil Corp.1991-04-18
DISCRETE PHOTOMETRIC CHEMISTRY ANALYSER (K904783)Industrial Chemical Measurement1991-04-18
SOPHYCAMERA DSX BODYTRAK (K911346)Sopha Medical Systems, Inc.1991-04-18
SCHNEIDER MAGNARAIL PROBING CATHETER (K910259)Schneider Intl., Ltd.1991-04-18
SYSTEM 7300 PULSE OXIMETER (K910521)Advanced Medical Instruments, Inc.1991-04-18
MODEL 6985M TEMPORARY UNIPOLAR LEAD EXTENDER KIT (K910630)Medtronic Vascular1991-04-18
INTIMAX(TM) IRRIGATION CATHETER (K911181)Applied Vascular Devices, Inc.1991-04-18
LEEP REDIKIT (K910253)CooperSurgical, Inc.1991-04-18
TAN CHONG GLOVE, HYPOALLERGENIC (K911146)Boston Medical Corp.1991-04-18
ANTIMICROBIAL AMIKACIN (K911303)Alamar Biosciences Laboratory, Inc.1991-04-18
QUIDEL HELICOBACTER PYLORI TEST (K903099)Quidel Corp.1991-04-17
PHONAK 9100 SC-AF ITE HEARING INSTRUMENT (K911211)Phonak, Inc.1991-04-17
IN-SIGHT SURGICAL INSTRUMENT KITS, DISPOSABLE (K910816)Insight International, Inc.1991-04-17
ANTIMICROBIAL AMPICILLIN/SULBACTAM (K911186)Alamar Biosciences Laboratory, Inc.1991-04-17
ALLERGEN MODULES FOR ALASTAT TM (K894227)Diagnostic Products Corp.1991-04-17
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