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
151681–151704 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 08, 1984
COOPER LASERSONICS, 8000 ND.YAGLASER
K841869 · LNK
Cooper Lasersonics, Inc.
Gastroenterology & Urology · 96d
Cleared Aug 08, 1984
LIFEMED LIFECOIL CATHETERS
K841929 · FKX
Lifemed of California
Gastroenterology & Urology · 90d
Cleared Aug 08, 1984
VAN-TEC OCCLUSION BALLOON CATHETER
K841941 · KOD
Van-Tec, Inc.
Gastroenterology & Urology · 89d
Cleared Aug 08, 1984
EMG MODULE, EMG1, W/OPTIONAL SPEAKER
K842124 · FAP
Endotek Corp.
Gastroenterology & Urology · 71d
Cleared Aug 08, 1984
G.I. CLEANSING KIT
K842130 · FCE
Mmi, Inc.
Gastroenterology & Urology · 70d
Cleared Aug 08, 1984
CORPAK URINARY DRAINAGE BAG
K842257 · KNX
Corpak Co.
Gastroenterology & Urology · 62d
Cleared Aug 08, 1984
ULTRA-VIOLET EMITTING SUNLAMP PRODUCT
K842384 · FTC
Sola-Tan Intl.
Radiology · 51d
Cleared Aug 08, 1984
SUR-FIT NIGHT DRAINAGE CONTAINER SET
K842395 · KNX
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 50d
Cleared Aug 08, 1984
ACCUSEAL LEG BAGS & EXTENSION TUBES
K842396 · KNX
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 50d
Cleared Aug 08, 1984
URIHESIVE SYS MALE EXTERNAL CATHETER
K842397 · KNX
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 50d
Cleared Aug 08, 1984
CLINICOMP R.C.I.
K842540 · KPT
Clinicomp, Inc.
Radiology · 37d
Cleared Aug 08, 1984
CAROLINA X-RAY CO. SIMPLAFLOAT TABLE
K842614 · IXQ
Carolina X-Ray Co., Inc.
Radiology · 34d
Cleared Aug 08, 1984
BIOLAS YAG 100
K842670
Advanced Biomedical Instruments
Cardiovascular · 29d
Cleared Aug 08, 1984
ORTHO ACTIVE KNEE BRACE
K842790
Ortho Active Appliances , Ltd.
Physical Medicine · 9d
Cleared Aug 08, 1984
ORTHO ACTIVE WRIST BRACE
K842791
Ortho Active Appliances , Ltd.
Physical Medicine · 9d
Cleared Aug 08, 1984
MENTOR 150 PLUS TRANSCUTANEOUS ELEC.
K842812 · GZJ
Mentor Corp.
Neurology · 21d
Cleared Aug 08, 1984
VACCESS FEMORAL CANNULA
K842864 · KNZ
Vas-Cath of Canada , Ltd.
Gastroenterology & Urology · 16d
Cleared Aug 08, 1984
KNEE-HIP MOBILIZER
K842881 · BXB
Joint Mobilizer Systems, Inc.
Physical Medicine · 16d
Cleared Aug 08, 1984
ANKLE MOBILIZER
K842882 · BXB
Joint Mobilizer Systems, Inc.
Physical Medicine · 16d
Cleared Aug 08, 1984
AMPCO PROCEDURE TRAYS / PACKS
K843114
Associated Medical Products Co.
General Hospital
Cleared Aug 07, 1984
RENEAU UNIT
K840841 · CBF
Reneau, Inc.
Anesthesiology · 165d
Cleared Aug 07, 1984
WOODLYN CLASSIC SLIT LAMP HSSL-CL
K841761 · HLI
Woodlyn, Inc.
Ophthalmic · 102d
Cleared Aug 07, 1984
WOODLYN CLASSIC JAVAL OPHTHALMOMETER
K841764 · HLI
Woodlyn, Inc.
Ophthalmic · 102d
Cleared Aug 07, 1984
WOODLYN STANDARD SLIT LAMP HSSL-ST
K841765 · HLQ
Woodlyn, Inc.
Ophthalmic · 102d