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
137569–137592 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 1987
SPERMICIDAL CONDOM
K874464 · HIS
Royal American Industries, Inc.
Obstetrics & Gynecology · 25d
Cleared Nov 20, 1987
KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR
K874537 · JSE
Lakewood Biochemical Co., Inc.
Microbiology · 17d
Cleared Nov 20, 1987
TODD-HEWITT BROTH (0.5ML)#3099 & (5.OML)#T3516
K874538 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 17d
Cleared Nov 20, 1987
TX-4(TENS) (SIGMA TENS)
K874550 · GZJ
Oms Medico, Inc.
Neurology · 16d
Cleared Nov 20, 1987
DYNATECH MR 250 MANUAL MICROELISA READER
K874598 · JTC
Dynatech Laboratories, Inc.
Microbiology · 11d
Cleared Nov 18, 1987
KTP/532 LASER
K873330 · LNK
Laserscope
Gastroenterology & Urology · 91d
Cleared Nov 17, 1987
DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF
K872006 · FGD
Mac Lee Medical Products
Gastroenterology & Urology · 175d
Cleared Nov 17, 1987
RICH-MAR CONDUCTIVE GEL
K872036 · IPF
Rich-Mar Corp.
Physical Medicine · 174d
Cleared Nov 17, 1987
BLOOD CONTAINMENT PACK
K872448 · LRO
Professional Medical Services
General & Plastic Surgery · 147d
Cleared Nov 17, 1987
SURFACE TEMPERATURE SCANNER
K873010 · FLL
Omega Medical Corp.
General Hospital · 105d
Cleared Nov 17, 1987
EDENTEC MULTI-CHANNEL RECORDER
K873081 · DQA
Edentec Corp.
Anesthesiology · 104d
Cleared Nov 17, 1987
HYPERTHERM TECHNOLOGIES' HEAT COMPRESS
K873364 · IMD
Hypertherm Technologies, Inc.
Physical Medicine · 88d
Cleared Nov 17, 1987
STAINLESS 22-13-5 SUTURE WIRE
K873645 · GAQ
Zimmer, Inc.
General & Plastic Surgery · 70d
Cleared Nov 17, 1987
COMFEEL ULCUS ULCER CARE SYSTEM
K873669 · FRO
Coloplast A/S
General & Plastic Surgery · 67d
Cleared Nov 17, 1987
SELECT SHOULDER SYSTEM
K873679 · HSD
Intermedics Orthopedics
Orthopedic · 64d
Cleared Nov 17, 1987
POIRIER KID-ROLLER MANUAL WHEELCHAIR
K874317 · IOR
Roseburg SA
Physical Medicine · 27d
Cleared Nov 17, 1987
PLASTIC TUBING CONNECTOR
K874360 · FPK
American Medical Technology, Inc.
General Hospital · 25d
Cleared Nov 16, 1987
ABCOM 1 CARDIAC OUTPUT MONITOR
K870857 · JOP
Applied Biometrics, Inc.
Cardiovascular · 258d
Cleared Nov 16, 1987
MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE
K871579 · HHR
Sharplan Lasers, Inc.
Obstetrics & Gynecology · 207d
Cleared Nov 16, 1987
FETAL SCALP ELECTRODE
K872057 · HGP
Medical Accessories, Inc.
Obstetrics & Gynecology · 172d
Cleared Nov 16, 1987
INSUFFLATOR TUBING
K872860 · HIG
Medline Industries, Inc.
Obstetrics & Gynecology · 118d
Cleared Nov 16, 1987
TECA/MEDELEC TTT THERMAL THRESHOLD TESTER
K872931 · LLN
Teca, Inc.
Neurology · 112d
Cleared Nov 16, 1987
OXYGEN/STERILE AIR GEN SYST/SURGICAL HANDPIECES
K873284 · CAW
Litton Systems, Inc.
Anesthesiology · 91d
Cleared Nov 16, 1987
STEREOTIX
K873618 · IZH
Thomson-Cgr Medical Corp.
Radiology · 69d