Atlas FDA

1993

4,167 FDA 510(k) clearances · Clearance year

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RecordFirmDate
DERMALON,SURGILON,OPHTHALON,& OPHTHALMIC NYLON SUT (K930586)Davis & Geck, Inc.1993-12-17
PHX TECHNOLOGIES CORP., BOWEL GRASPER DEVICE (K934021)Phx Technologies Corp.1993-12-17
PHX TECHNOLOGIES CORP., ALLIGATOR GRASPER DEVICE (K934027)Phx Technologies Corp.1993-12-17
MODEL 508 PATIENT MONITOR (K921309)Criticare Systems, Inc.1993-12-17
SIGMA BUN REAGENT (K933679)Sigma Chemical Co.1993-12-17
PHX TECHNOLOGIES CORP, SPONGE GRASPER DEVICE (K934025)Phx Technologies Corp.1993-12-17
EMDS ALBUMIN (ALB) TEST (K935179)Em Diagnostic Systems, Inc.1993-12-17
NON-ABSORBABLE SURGICAL SUTURES (K930517)Alcon Laboratories1993-12-17
SIGMA CO2 ALKALINE BUFFER REAGENT (K933691)Sigma Chemical Co.1993-12-17
ULTRABRONZ SERIES 400 TANNING BED (K931660)Eurocut, Ltd.1993-12-17
SUPRAMID SUTURE (K931613)S. Jackson, Inc.1993-12-17
LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE (K930941)Lukens Medical Corp.1993-12-17
PHX TECHNOLOGIES CORP., SUTURE GRASPER DEVICE (K934024)Phx Technologies Corp.1993-12-17
ARTERIAL & VENOUS BLOOD TUBING SETS FOR HEMODIALYSIS (K934803)Baxter Healthcare Corp1993-12-17
PLAIN, MILD CHROMIC AND CHROMIC SURGICAL GUT SUTUR (K930589)Davis & Geck, Inc.1993-12-17
I-STAT IONIZED CALCIUM TEST (K934642)I-Stat Corp.1993-12-17
LUKENS STAINLESS STEEL SURGICAL SUTURE (K930940)Lukens Medical Corp.1993-12-17
SILK SUTURES-REVISED LABELING (K926168)Look, Inc.1993-12-17
MOPYLEN SUTURE (K931614)S. Jackson, Inc.1993-12-17
PHX TECH SINGLE ACTION HEAVY-TOOTH JAW CLAW GRASPER (K934022)Phx Technologies Corp.1993-12-17
ZSI LAPAROSCOPES-GENERAL & PLASTIC SURGERY (K926181)Zinnanti Surgical Instruments, Inc.1993-12-17
URINE METER (K935578)Puritas Health Care, Inc.1993-12-17
REVISED LABELING FOR POLYPROPYLENE SUTURE (K926588)Look, Inc.1993-12-17
REVISED LABELING FOR NYLON SUTURE (POLYAMIDE) (K926587)Look, Inc.1993-12-17
SILK SUTURES (K930590)Davis & Geck, Inc.1993-12-17
XDCS-100 (K932083)Microwave Medical Systems, Inc.1993-12-16
516YT DISPLAY DRIVER (K926219)Vidco, Inc.1993-12-16
CLASSIQUE (K932899)Hemispheres Marketing Co. , Ltd.1993-12-16
BLD HEATED BREATHING CIRCUIT W/EXHALATION VALVE (K931487)Bird Life Design1993-12-16
UVISOL AND UVISOL II (K934808)National Biological Corp.1993-12-16
STERILE, DISPOSABLE ENDOSCOPIC TRUMPET VALVE (K934098)Phx Technologies Corp.1993-12-16
ATRIUM POLYPROPYLENE MESH (K930669)Atrium Medical Corp.1993-12-16
TROCAR REDUCER WITH GAS CLHECK VALVE (K934185)Phx Technologies Corp.1993-12-16
CHOLESTEROL (CHOL) TEST ITEM NO. 65410 (K935136)Em Diagnostic Systems, Inc.1993-12-16
BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE (K934084)Bioenterics Corp.1993-12-16
TOTAL PROTEIN TEST (TPRO) (K935174)Em Diagnostic Systems, Inc.1993-12-16
ACS.018 HI-TORQUE FLOPPY GUIDE WIRE - ACS HI-TORQUE FLOPPY EXTRA SUPPORT GUIDE WIRE (K934602)Advanced Cardiovascular Systems, Inc.1993-12-16
TRACFINDER II (K924108)Ep Technologies, Inc.1993-12-16
STERILIZATION WRAP-STERISHEET (K931202)Arjo Wiggins Medical, Inc.1993-12-16
IRON TEST (K935176)Em Diagnostic Systems, Inc.1993-12-16
LIFEPAK 9 DEFIBRILLATOR/MONITOR (K935674)Physio-Control Corp.1993-12-16
STEEROCATH II (K924109)Ep Technologies, Inc.1993-12-16
GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST (K935177)Em Diagnostic Systems, Inc.1993-12-16
LACTATE DEHYDROGENASE (LD) (K935175)Em Diagnostic Systems, Inc.1993-12-16
AUTOANTIBODY PROFILE-6 ELISA TEST SYSTEM (K933267)Zeus Scientific, Inc.1993-12-15
MODIFICATIONS TO INTRA-AORTIC BALLOONS (K932268)Kontron Instruments, Inc.1993-12-15
PYR TEST KIT (K931865)Hardy Diagnostics1993-12-15
NUCLEAR ASSOCIATES KNIGHT SR., KNIGHT JR. AND SESAM PORTABLE RADIOGRAPHY CASSETTE HOLDERS (K935397)Victoreen, Inc.1993-12-15
POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE) (K933664)Siemens Gammasonics, Inc.1993-12-15
PAL (PERSONAL AMPLIFIER FOR LISTENING) (K933963)Hearing Care Products, Inc.1993-12-15
PANORAMIC X-RAY UNITS, MODIFICATION (K934063)Planmeca Oy1993-12-15
8260 SERIES 3M PROGRAMMABLE HEARING INSTRUMENTS (K935095)3M Company1993-12-15
CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE (K932259)Clarus Medical Systems, Inc.1993-12-15
MIRACLE EAR MODEL SHARP II CANAL (K935265)Miracle-Ear, Inc.1993-12-15
MPQ-42 (K934944)Elema-Schonander, Inc.1993-12-15
MIRACLE EAR MODEL SHARP II MICRO CANAL HEARING AID (K935266)Miracle-Ear, Inc.1993-12-15
ACTION WIZARD PEDIATRIC MANUAL WHEELCHAIR (K934646)Invacare Corp.1993-12-15
SOUNDRIGHT, SHP (K935420)Soundright Hearing Products1993-12-15
BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET (K932163)Helix Medical, Inc.1993-12-15
SCIMED(R) DISPATCH(TM) CORONARY INFUSION CATHETER (K932616)Scimed Life Systems, Inc.1993-12-15
MARTIN LEWIS WITH LINOCMYCIN (K931864)Hardy Diagnostics1993-12-15
CARAPACE STERILE CAST PADDING (K931672)Carapace, Inc.1993-12-15
HUBER NEEDLE INFUSION SET (K932638)Douglas Medical Products Corp.1993-12-14
CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH (K933050)Critikon Company, LLC1993-12-14
MERIT (K933356)Philips Medical Systems (Cleveland), Inc.1993-12-14
PHASED ARRAY/BILATERAL QUADRATURE CONTOUR COIL (K932091)Magnetic Research, Inc.1993-12-14
BARE-FIBER ENDOILLUMINATOR (K933208)Surgical Technologies, Inc.1993-12-14
FORCEPS, BIOPSY, GASTROINTESTINAL (K934186)Primed Instruments, Inc.1993-12-14
KONICA SRX-301 AUTOMATIC X-RAY FILM PROCESSOR (K931317)Konica Medical Corp.1993-12-14
ZEISS OPMILAS 144 SURGICAL LASERS (K932376)Carl Zeiss, Inc.1993-12-14
BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR (K934310)Respironics, Inc.1993-12-14
IMPAX 3000 (K934832)Heraeus Kulzer, Inc.1993-12-14
KONICA SRX-501A AUTOMATIC X-RAY FILM PROCESSOR (K931315)Konica Medical Corp.1993-12-14
KONICA DS-7 AUTOMATIC X-RAY FILM PROCESSOR (K931316)Konica Medical Corp.1993-12-14
IMAGEACCESS SYSTEM (K931454)Image Premastering Services, Inc.1993-12-14
KONICA LD-4500 LASER DIGITIZER (K933830)Konica Medical Corp.1993-12-14
MERIT (K931656)Picker International1993-12-14
KAWASUMI LABORATORIES K-CUFF (K930012)Kawasumi Laboratories Co., Ltd.1993-12-14
LASER GAS MIXTURE (K935034)Tri-Gas, Inc.1993-12-14
HEARTVIEW(R) CORONARY ANGIOGRAPH DIAGRAM/REPORT SY (K932410)Heartware Intl. Corp.1993-12-13
MODEL ALPHA TS-2 (K935004)Dpa Consulting, Inc.1993-12-13
PULSE ELECTRIC TOOTHBRUSH (K933829)Dentatech Corp.1993-12-13
STRATO MEDICAL SINGLE LUMEN VALVED CATHETER (K924851)Strato Medical Corp.1993-12-13
PHILIPS GYROSCAN TN 15 (K932645)Philips Medical Systems, Inc.1993-12-13
XYZ PADS (K933159)Aso Corp.1993-12-13
INTRASCAN(R) MINI-PACS (K934311)Markcare Medical Systems, Inc.1993-12-13
SHIMADZU UD150L-R X-RAY HIGH VOLTAGE GENERATOR (K934967)Shimadzu Corp.1993-12-13
MODIFICATION OF KENDALL CURASORB CALCIUM ALGINATE WOUND DRESSING (K933689)Kendall Healthcare Products Co. Div.Of Tyco Health1993-12-13
LACERATION TRAY (K932036)Clinipad Corp.1993-12-13
STERI-OSS TITANIUM SCREW SERIES IMPLANT (K923484)Steri-Oss, Inc.1993-12-13
CONCEPT ONE (K933777)Innerscan, Inc.1993-12-13
MEDSURG MARSHMALLOW TRAY (K920421)Medsurg Industries, Inc.1993-12-13
MODEL 500-6 RADIATION THERAPY IONIZATION CHAMBER (K932342)Victoreen, Inc.1993-12-13
ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES (K933812)Advanced Surgical, Inc.1993-12-13
BASIC SKIN PREP TRAY (K932361)Mcbar Industries1993-12-13
INSTA-FLO (K935209)Medtec, Inc.1993-12-13
FASTFIL (K934184)Scientific Pharmaceuticals, Inc.1993-12-13
RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM (K934519)Medtec, Inc.1993-12-13
MEDSCAN 12 (K933632)Vidar Systems Corp.1993-12-13
RADIONUCLIDE CATHETERS, RNC-A, RNC-G, RNC-U (K923697)Radionics, Inc.1993-12-13
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Every clearance here is in the API, with alerts when new ones post.