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
139921–139944 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 20, 1987
DUAL SUBSTRATE ANA
K871395 · DHN
Val Tech Diagnostics, Inc.
Immunology · 13d
Cleared Apr 17, 1987
NEONATAL FEEDING KIT
K864683 · KNT
Salt Creek Medical Technologies
Gastroenterology & Urology · 136d
Cleared Apr 17, 1987
CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER
K865029 · FPB
Travenol Laboratories, S.A.
General Hospital · 115d
Cleared Apr 17, 1987
FOLEY CATHETER
K870165 · KOD
Acorn Medical Products
Gastroenterology & Urology · 93d
Cleared Apr 17, 1987
HOMEPRO II VOLUMETRIC INFUSION PUMP
K870444 · FRN
American Edwards Laboratories
General Hospital · 73d
Cleared Apr 17, 1987
E-Z LOOP
K870577 · EXB
John F. Greer Co., Inc.
Gastroenterology & Urology · 66d
Cleared Apr 17, 1987
OPTICAL CONSOLE(TM) AND OPTICAL CATHETER(TM)
K870680 · FET
Medline Industries, Inc.
Gastroenterology & Urology · 57d
Cleared Apr 17, 1987
ADG PATELLAR COMPONENT
K870702 · JWH
Buckman Co., Inc.
Orthopedic · 56d
Cleared Apr 17, 1987
THERMAL COAGULATOR
K870705 · KNS
Microvasive
Gastroenterology & Urology · 56d
Cleared Apr 17, 1987
MODIFIED CASTLE POWERCLAVE
K870975 · FLE
Castle Co.
General Hospital · 38d
Cleared Apr 16, 1987
SUNGLASSES AND SUNGLASS FRAMES VARIOUS COLORS
K870178 · HQY
Polinelli
Ophthalmic · 91d
Cleared Apr 16, 1987
DISPOSABLE SYRINGE W/O NEEDLE
K870190 · FMF
Can-Am Surgical Corp.
General Hospital · 86d
Cleared Apr 16, 1987
DISPOSABLE SYRINGE WITH NEEDLE
K870191 · FMF
Can-Am Surgical Corp.
General Hospital · 86d
Cleared Apr 16, 1987
DISPOSABLE SYRINGE TUBERCULIN W/NEEDLE
K870192 · FMF
Can-Am Surgical Corp.
General Hospital · 86d
Cleared Apr 16, 1987
LEM SUNGLASSES & FRAMES DIFF. COLORS AND DESIGNS
K870219 · HQY
Lem Srl.
Ophthalmic · 85d
Cleared Apr 16, 1987
LEM SPECTACLE FRAMES DIFFERENT COLORS AND DESIGNS
K870220 · HQZ
Lem Srl.
Ophthalmic · 85d
Cleared Apr 16, 1987
AUDIOMETER
K870337 · ETW
Bio-Logic Systems Corp.
Ear, Nose, Throat · 78d
Cleared Apr 16, 1987
CURETTE, PERIODONTAL, COLUMBIA UNIVERSITY
K870590 · EMS
Military Engineering, Inc.
Dental · 65d
Cleared Apr 16, 1987
OMRON DIGITAL FEVER THERMOMETER MODEL MC-7
K870956 · FLL
Omron Electronics, Inc.
General Hospital · 37d
Cleared Apr 16, 1987
CAPSULECTOMER CYSTOTOME
K871365 · HNY
Noetix, Inc.
Ophthalmic · 9d
Cleared Apr 15, 1987
SWANSON TITANIUM CONDYLAR IMPLANT
K864488 · KYI
Dow Corning Wright
Orthopedic · 153d
Cleared Apr 15, 1987
SWANSON TITANIUM TRAPEZIUM IMPLANT
K864489 · KYI
Dow Corning Wright
Orthopedic · 153d
Cleared Apr 15, 1987
SWANSON TITANIUM CARPAL SCAPHOID IMPLANT
K864490 · KWO
Dow Corning Wright
Orthopedic · 153d
Cleared Apr 15, 1987
SWANSON TITANIUM CARPAL LUNATE IMPLANT
K864491 · KWN
Dow Corning Wright
Orthopedic · 153d