FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
97777–97800 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 1996
KETAC-MOLAR APLICAP
K960954 · EMA
Espe GmbH & Co. Kg.
Dental · 66d
Cleared May 16, 1996
DURALASTIC SHEETING II
K961057 · MIB
Rand Scientific Corp.
General & Plastic Surgery · 59d
Cleared May 16, 1996
BURN-AID HYDROGEL,BURN DRESSING,BURN BLANKET
K961067 · MGQ
Medtrak Intl., Inc.
General & Plastic Surgery · 59d
Cleared May 16, 1996
DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS
K961087 · GEI
Debusk Knitting Mills, Div. Deroyal...
General & Plastic Surgery · 58d
Cleared May 16, 1996
VIEWPOINT
K961168 · GAW
Philips Medical Systems (Cleveland),...
General & Plastic Surgery · 52d
Cleared May 16, 1996
HYDRO-FLEX LI LAPAROSCOPIC IRRIGATION SYSTEM
K961224 · GCJ
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery · 48d
Cleared May 16, 1996
STUSSY SUNGLASSES/A.J. MORGAN SUNGLASSES
K961286 · HQY
Intl. Optical Mfg. Co., Ltd.
Ophthalmic · 43d
Cleared May 16, 1996
STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS...
K961524 · HNY
Sterilab, Inc.
Ophthalmic · 24d
Cleared May 16, 1996
CHRONOSWISS,BALENO,BONIA,OTMAR ALT, NEW JERSEY
K961746 · HQY
Eurotrends Eyewear, Inc.
Ophthalmic · 10d
Cleared May 15, 1996
MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER
K954457 · KRA
Medi-Tech, Inc.
Cardiovascular · 233d
Cleared May 15, 1996
PAGEWRITER 200, 200I CARDIOGRAPH & INTERPRETIVE CARDIO
K954980 · LOS
Hewlett-Packard Co.
Cardiovascular · 197d
Cleared May 15, 1996
ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL
K955356 · CGI
Diagnostic Systems Laboratories, Inc.
Chemistry · 176d
Cleared May 15, 1996
DIASTAT VASCULAR ACCESS GRAFT
K955533 · DYF
W.L. Gore & Associates, Inc.
Cardiovascular · 162d
Cleared May 15, 1996
V2 INJECTION SITE
K955585 · FPA
B.Braun Medical, Inc.
General Hospital · 160d
Cleared May 15, 1996
RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY
K955689 · DWS
Contour Fabricators of Florida, Inc.
Cardiovascular · 153d
Cleared May 15, 1996
OXITEMP, 3301T SA
K960058 · DQA
Bci Intl., Inc.
Anesthesiology · 134d
Cleared May 15, 1996
PROTECTIVE LATEX POWDERED GLOVES
K960277 · LYY
Highactive Sdn. Bhd.
General Hospital · 117d
Cleared May 15, 1996
8 FR.-40CC ARROW FLEX INTRA-AORTIC BALLOON CATHETER WITH BLUE FLEX TIP,...
K960713 · DSP
Arrow Intl., Inc.
Cardiovascular · 84d
Cleared May 15, 1996
GALVA 5-T
K960969 · GZJ
Zimmer Elektromedizin GmbH
Neurology · 65d
Cleared May 15, 1996
SCIMED CHOICE/PTCA GUIDE WIRE/PLUS PTCA GUIDE WIRE/EXCHANGE PTCA GUIDE WIRE
K961015 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 63d
Cleared May 15, 1996
CHEM-CHEX STAT
K961195 · JJY
Streck Laboratories, Inc.
Chemistry · 49d
Cleared May 15, 1996
EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA)
K961196 · CDN
Johnson & Johnson Clinical...
Chemistry · 49d
Cleared May 15, 1996
SYNCHRON SYSTEMS VALPROIC ACID (VPA) REAGENT
K961256 · LEG
Beckman Instruments, Inc.
Toxicology · 44d
Cleared May 15, 1996
AED CALIBRATORS
K961273 · DKB
Diagnostic Reagents, Inc.
Toxicology · 43d