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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
121729–121752 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 25, 1991
TONGUETOUCH KEYPAD AND ZOFCOM CONTROL SYSTEM
K911101 · IQA
Zofcom, Inc.
Physical Medicine · 43d
Cleared Apr 25, 1991
APPLICATOR LOOP SUTURES
K911157 · GCJ
Northgate Technologies, Inc.
General & Plastic Surgery · 41d
Cleared Apr 25, 1991
STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE
K911189 · GAW
Internacional Farmaceutica, S.A. DE C.V.
General & Plastic Surgery · 38d
Cleared Apr 25, 1991
KENDALL PEDIATRIC ULTRAMER POLYURETHANE CATHETER
K911242 · KOD
Kendall Healthcare Products Co....
Gastroenterology & Urology · 35d
Cleared Apr 25, 1991
EUDERMIC SURGICAL GLOVES
K911245 · KGO
Bd Becton Dickinson Vacutainer...
General Hospital · 35d
Cleared Apr 25, 1991
KENDALL PEDIATRIC URINE METER
K911258 · EXR
Kendall Healthcare Products Co....
Gastroenterology & Urology · 34d
Cleared Apr 25, 1991
BARD 3000 PLUS URETEROSCOPY SYSTEM
K911411 · FGB
C.R. Bard, Inc.
Gastroenterology & Urology · 24d
Cleared Apr 25, 1991
SURGITRON
K911461 · GCI
Ellman Intl. Mfg., Inc.
General & Plastic Surgery · 22d
Cleared Apr 25, 1991
LAPAROSCOPIC SUCTION/IRRIGATION CANNULA
K911486 · GCJ
United States Endoscopy Group, Inc.
General & Plastic Surgery · 21d
Cleared Apr 25, 1991
LAPAROSCOPIC IRRIGATION PUMP
K911493 · GCJ
United States Endoscopy Group, Inc.
General & Plastic Surgery · 21d
Cleared Apr 25, 1991
PATIENT EXAMINATION LATEX GLOVES (NON-STERILE)
K911694 · LYY
Guthrie Medicare Products (Melaka)...
General Hospital · 9d
Cleared Apr 24, 1991
MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT
K904538 · CAI
Mauna Loa Medical, Inc.
Anesthesiology · 202d
Cleared Apr 24, 1991
SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)
K910204 · DQO
Baxter Healthcare Corp
Cardiovascular · 98d
Cleared Apr 24, 1991
ACID CONCENTRATE SOLUTIONS
K910319 · KPO
Biopharm, Inc.
Gastroenterology & Urology · 90d
Cleared Apr 24, 1991
FUJI COMPUTED RADIOGRAPHY SYSTEM FCR 7501
K910437 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 83d
Cleared Apr 24, 1991
ROCHE REAGENT FOR TOTAL BILIRUBIN
K910591 · CIG
Roche Diagnostic Systems, Inc.
Chemistry · 71d
Cleared Apr 24, 1991
ROCHE REAGENT FOR DIRECT BILIRUBIN
K910593 · CIG
Roche Diagnostic Systems, Inc.
Chemistry · 71d
Cleared Apr 24, 1991
BAG SPIGOT
K910673 · KPE
Procedure Products, Inc.
General Hospital · 68d
Cleared Apr 24, 1991
GRADUATED CYLINDER OF EXTERNAL DRAINAGE SET
K910853 · JXG
Cordis Corp.
Neurology · 55d
Cleared Apr 24, 1991
NOVOSTE GUIDING CATHETER
K911527 · DQY
Novoste Corp.
Cardiovascular · 20d
Cleared Apr 24, 1991
PHARMACIA SPECIFIC IGE CONTROL
K911631 · DGC
Pharmacia, Inc.
Immunology · 13d
Cleared Apr 23, 1991
ANESTHESIA CONDUCTION FILTER
K902666 · BSN
Arbor Technologies, Inc.
Anesthesiology · 309d
Cleared Apr 23, 1991
CCI CORNEAL SCARIFIER
K904505 · GDX
Buckman Co., Inc.
General & Plastic Surgery · 203d
Cleared Apr 23, 1991
D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEM
K904599 · JWM
Digital Design, Inc.
Radiology · 195d