Atlas FDA

1988

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

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RecordFirmDate
ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINES (K881817)Roche Diagnostic Systems, Inc.1988-07-29
SET, INTRAVASCULAR (K881975)Primrose Medical, Inc.1988-07-29
STORZ UNIV IRRIGAT/ASPIRA & PHACOEMULSIFCATION PAC (K882240)Storz Instrument Co.1988-07-29
NEOLENS SUNGLASSES (K882813)Neolens, Inc.1988-07-29
A PORT IMPLANT VASCULAR ACCESS SYSTEM - DETACHED (K882230)Therex Corp.1988-07-29
BOLDREY PERIPHERAL RETINAL LENS (K882574)Ocular Instruments, Inc.1988-07-29
GENT-L-KARE STERILE URINARY LEG BAG (K881217)Geneva Laboratories, Inc.1988-07-29
NEOLENS PRESCRIPTION SPECTACLE LENS (K882814)Neolens, Inc.1988-07-29
PRESSURE INFUSOR (K881977)Primrose Medical, Inc.1988-07-29
ABUSCREEN(R) ONTRAK(TM) FOR THC (K881814)Roche Diagnostic Systems, Inc.1988-07-29
GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK. (K882450)Diamond Sensor Systems1988-07-28
MODIFIED INTENDED USE OF MONOJECT BONE MARROW NEED (K883014)Sherwood Medical Co.1988-07-28
SLIP-COAT(TM) CATHETERS (K882796)Cook, Inc.1988-07-28
HI-LO TABLE, MODEL 820-05 (K882917)Tri W-G, Inc.1988-07-28
HARBOR CENTRAL VENOUS CATHETER (K881884)Harbor Medical Devices, Inc.1988-07-28
QTEST(TM) PREGNANCY (K882086)Quidel Corp.1988-07-28
ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES (K881816)Roche Diagnostic Systems, Inc.1988-07-28
DULBECCO'S PHOSPHATE BUFFERED SALINE NO. 210-3025 (K882865)J R Scientific1988-07-28
HANK'S BALANCED SALTS NO. 200-2510 (K882844)J R Scientific1988-07-28
MEDRAD OPEN ENDED GUIDEWIRE (K880332)Medrad, Inc.1988-07-28
CORDIS PTA DILATATION CATHETERS (K880612)Cordis Corp.1988-07-28
GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER (K881213)Geneva Laboratories, Inc.1988-07-28
NUTRIENT MIXTURE F-12 (HAM), NO. 210-3551 (K882858)J R Scientific1988-07-28
DULBECCO'S PHOSPHATE BUFFERED SALINE, NO 200-2525 (K882852)J R Scientific1988-07-28
FIELDTEX HEMATOXYLIN (K882873)Anatech, Ltd.1988-07-28
CARDIOCAP(TM) CMO-104 MONITOR (K882093)Datex Division Instrumentarium Corp.1988-07-28
MODIFIED PERIPHERAL DILATATION CATHETERS (K875175)Schneider-Shilley (Usa)1988-07-28
INTRA-ART(TM) INTERNAL MAMMARY INFUSION CATHETER (K882034)Buckman Co., Inc.1988-07-28
EARLE'S BALANCED SALTS NO. 200-2500 (K882845)J R Scientific1988-07-28
EARLE'S BALANCED SALTS (EBSS) NO. 200-2505 (K882842)J R Scientific1988-07-28
MOTORIZED PARALLEL BAR, MODEL 110 (K882916)Tri W-G, Inc.1988-07-28
HANK'S BALANCED SALTS (HBSS) NO. 200-2521 (K882841)J R Scientific1988-07-28
DULBECCO'S PHOSPHATE BUFFERED SALINE NO. 210-3020 (K882859)J R Scientific1988-07-28
HANKS' BALANCED SALT SOLUTION (HBSS) NO. 210-3011 (K882864)J R Scientific1988-07-28
AMERLITE LH-30 ASSAY, LAN.0082/2082 240/144 TEST (K880933)Amersham Corp.1988-07-28
MINIMON 7132B PATIENT MONITOR (K882198)Kontron Instruments, Inc.1988-07-28
MODIFIED MODEL SSD-650 SYSTEM (K873452)Ge Medical Systems Information Technologies1988-07-28
MINIMUM ESSENTIAL MEDIUM EAGLE, NO. 200-2180 (K882838)J R Scientific1988-07-28
ZINC FORMALIN (K882874)Anatech, Ltd.1988-07-28
SIGMA 1 WOBBLER BIOPSY KIT (K882673)Kontron Instruments, Inc.1988-07-28
BAGGISH, HYSTEROSCOPE (K881249)Bryan Corp.1988-07-28
GENT-L-KARE CLEANSING ENEMA SET (K881218)Geneva Laboratories, Inc.1988-07-28
HANKS' BALANCED SALT SOLUTION NO. 210-3015 (K882855)J R Scientific1988-07-28
EARLE'S BALANCED SALTS (EBSS) NO. 200-2506 (K882839)J R Scientific1988-07-28
KIRSCHNER SUPER-FIXATION SYSTEM (K881896)Kirschner Medical Corp.1988-07-28
BREVET CASSETTE STERILIZATION MODULE (K882617)Brevet, Inc.1988-07-28
CLEARBLUE EASY (K882416)Unipath , Ltd.1988-07-28
HEART-CHILL SALINE SLUSH PAD (K882035)Buckman Co., Inc.1988-07-28
HANK'S BALANCED SALTS NO. 200-2515 (K882843)J R Scientific1988-07-28
SAKURA-MEDSCAND SCA-1800 AUTOMATIC COVERSLIPPER (K882881)Sakura Finetek U.S.A., Inc.1988-07-28
VITALERT 2000 VITAL SIGNS MONITOR (K882031)Draeger Medical, Inc.1988-07-28
MODEL 404 ADULT HEART RATE/BLOOD PRESSURE MONITOR (K882188)Ivy Biomedical Systems, Inc.1988-07-28
HANKS' BALANCED SALTS NO. 210-3010 (K882857)J R Scientific1988-07-28
HANK'S BALANCED SALTS (HBSS) NO. 200-2520 (K882840)J R Scientific1988-07-28
EARLE'S BALANCED SALT SOLUTION NO. 210-3005 (K882856)J R Scientific1988-07-28
PROPAQ 104(TM) (K882085)Protocol Systems, Inc.1988-07-28
EARLE'S BALANCED SALT SOLUTION (EBSS) NO. 210-3000 (K882866)J R Scientific1988-07-28
MODEL BPS08 BLOOD PRESSURE MODULE (K881155)Fresenius USA, Inc.1988-07-28
YESNG SUPER FRECATOR (K882903)Ferguson Medical1988-07-28
TUNNELING STYLET (K882097)Quinton, Inc.1988-07-28
DULBECCO'S PHOSPHATE BUFFERED SALINE NO. 200-2530 (K882862)J R Scientific1988-07-28
BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER (K881968)Biodynamics Corp.1988-07-28
CATHETER WITHDRAWAL UNIT (K881878)Eris Medical Technology1988-07-28
LIFEPAK 9 DEFIBRILLATOR AND CARDIAC MONITOR (K881153)Physio-Control Corp.1988-07-27
MODIFIED PERMAGUM ADHESIVE (K881838)Espe GmbH (Us)1988-07-27
MODIFIED EXTRAVAKIT (K882025)Extravakit, Inc.1988-07-27
TECNOL SECURE-ALL PELVIC TRACTION BELT (K882640)Tecnol New Jersey Wound Care, Inc.1988-07-27
WILLIAMS ACS MARKER NEEDLE (K882036)Buckman Co., Inc.1988-07-27
DISPOSEABLE MENSTRUAL PANTY (K882109)Glamor Plus Co.1988-07-26
BATTERY PACKS (OTHER THAN CV) (K881885)Dowit Service Co., Inc.1988-07-26
MEDICAM MC-7 AND RP-7 SURGICAL CAMERAS (K882924)M.P. Video, Inc.1988-07-26
SYRETTE (K881992)Oratec Corp.1988-07-26
UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE (K881796)Universal Medical Instrument Corp.1988-07-26
XENON CT (K875088)Siemens Medical Solutions USA, Inc.1988-07-26
CONTINUOUS ARTERIAL/VENOUS HEMOFILTRATION TRAY (K880775)Medsurg Industries, Inc.1988-07-25
EURO-MED ENDO-CURETTE (K882606)Buckman Co., Inc.1988-07-25
ITE TYPE HEARING AID H.A.F. MODEL ELITE (K881754)Brown Hearing Aid Centers1988-07-25
HYCEL QUICK-LYSING HEMOGLOBIN REAGENT (K882490)R&D Systems, Inc.1988-07-25
ACS HI-TORQUE STANDARD & INTERMEDI. GUIDE WIRE (K881787)Advanced Cardiovascular Systems, Inc.1988-07-25
E-Z-EM(R) LUFKIN BIOPSY NEEDLES (K882601)E-Z-Em, Inc.1988-07-25
BURROWS-KNUDSON AUTOMATED LUNG FUNCTION INTER. SYS (K880550)Medimicro Systems, Inc.1988-07-25
GENERAL SURGICAL TABLE AND ACCESSORIES (K882660)American Sterilizer Co.1988-07-25
3M CARPAL TUNNEL (K881703)3M Company1988-07-25
SONAR-AID(R) ULTRASOUND STANDOFF PAD (K874943)Geistlich-Pharma1988-07-25
CONTRA ANGLE HANDPIECE ATTACH. W/PROPHYLAXIS CUP (K881985)Denticator1988-07-25
ENDO C BRUSH (K882628)Milex Products, Inc.1988-07-25
ABBOTT TESTPACK CHLAMYDIA (K880783)Abbott Laboratories1988-07-25
PROFICIENT(TM) PROPHYLAXIS ANGLE (K881974)Block Drug Company, Inc.1988-07-25
ALTERNATE BLOOD PORT DESIGN FOR ADDIT. MEMB. OF CA (K882680)Baxter Healthcare Corp1988-07-22
CR-39 PLASTIC LENSES FOR EYEGLASSES (K882308)Automated Lens System1988-07-22
CHANGE TO CATHODE POWDER SPECIFICATION (K881904)Telectronics and Cordis Pacing Systems1988-07-22
MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004 (K882429)Tpl-Cordis, Inc.1988-07-22
MODIFIED MODEL 5455 DISPOSABLE SURGICAL CABLE (K882174)Medtronic Andover Medical, Inc.1988-07-22
CARD GUARD, MODEL CG-2000 (K882290)Card Guard Scientific Survival , Ltd.1988-07-22
DERMAPOINTS MODEL 200 THERAPEUTIC MASSAGER (K881081)Ferguson Medical1988-07-21
DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023 (K882259)Diagnostic Chemicals, Ltd. (Usa)1988-07-21
RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR (K881931)Rondex Products, Inc.1988-07-21
DERMAPOINTS MODEL 100 THERAPEUTIC MASSAGER (K881080)Ferguson Medical1988-07-21
A.X.T. SPOTFILM DEVICE (K882492)Applied X-Ray Technologies, Inc.1988-07-21
ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI. (K882549)Acuson Corp.1988-07-21
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