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
157777–157800 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 27, 1983
UVB LIGHT BOX TANNING BOOTH
K837032
Sun Shanty, Inc.
Radiology · 64d
Cleared Jan 26, 1983
SIGMA 7000
K820038 · FRN
Sigma
General Hospital · 19d
Cleared Jan 26, 1983
MODEL 460 INTERMITTENT MEDICATION DELIV
K823018 · FLN
Y
General Hospital · 105d
Cleared Jan 26, 1983
MEDISYSTEMS FISTULA NEEDLES
K823068 · KOC
Medisystems Corp.
Gastroenterology & Urology · 99d
Cleared Jan 26, 1983
M2100 ANTEPARTUM FETAL MONITOR
K823081 · HGM
Huntleigh Technology, Inc.
Obstetrics & Gynecology · 99d
Cleared Jan 26, 1983
M2000 INTRAPARTUM FETAL MONITOR
K823188 · HGM
Huntleigh Technology, Inc.
Obstetrics & Gynecology · 92d
Cleared Jan 26, 1983
MODEL 78670A
K823268 · LDD
Hewlett-Packard Co.
Cardiovascular · 85d
Cleared Jan 26, 1983
PC-205 TENCKHOFF CATHETER ROD OBTURATOR
K823296 · FKX
Medigroup
Gastroenterology & Urology · 82d
Cleared Jan 26, 1983
QUILL CATHETER GUIDE
K823303 · FKX
Medigroup
Gastroenterology & Urology · 82d
Cleared Jan 26, 1983
DIALATORS PC-203 & 202
K823330 · FKX
Medigroup
Gastroenterology & Urology · 79d
Cleared Jan 26, 1983
PC-204 TUNNELOR
K823331 · FKX
Medigroup
Gastroenterology & Urology · 79d
Cleared Jan 26, 1983
PC 201A LOCKING SLEEVE
K823390 · FKX
Medigroup
Gastroenterology & Urology · 82d
Cleared Jan 26, 1983
POUR BOTTLE DECANTER #2010
K823538 · KPE
Medi-Plant Intl.
General Hospital · 57d
Cleared Jan 26, 1983
MICRO Z BLOOD COLLECTING NEEDLES
K823696 · FMI
Hospital Products Co.
Chemistry · 49d
Cleared Jan 26, 1983
BICEPS ELECTROCAUTERY SYSTEM
K823755 · HAM
Squibb Diagnostics
General & Plastic Surgery · 43d
Cleared Jan 26, 1983
EVERBOND GLASS IONOMER CEMENT
K823795 · EMA
Sybron Corp.
Dental · 30d
Cleared Jan 26, 1983
IMPRA PERITONEAL CATHETER
K823857 · FKX
Impra, Inc.
Gastroenterology & Urology · 35d
Cleared Jan 26, 1983
SOFT GRIP UNI-HANDLE
K823913 · EJB
Treace Medical, Inc.
Dental · 29d
Cleared Jan 26, 1983
TOOTH CONDITIONER
K823928 · DYH
Dentsply Intl.
Dental · 28d
Cleared Jan 26, 1983
KARICKHOFF KERATOSCOPE
K830008 · HLR
Surgidev Corp.
Ophthalmic · 23d
Cleared Jan 26, 1983
SUPERJET LANCET
K830010 · FMK
Medprobe Laboratories
General & Plastic Surgery
Cleared Jan 26, 1983
VOLUMETRIC PUMP ADMIN. SETS
K830017 · FRN
Travenol Laboratories, S.A.
General Hospital · 23d
Cleared Jan 26, 1983
SAFE-T ARM BOARD
K830018 · BTX
Harvey A. Turner, M.D.
General & Plastic Surgery · 23d
Cleared Jan 26, 1983
SIGMA 7000-6000 INFUSION PUMPS
K830038 · FRN
Sigma
General Hospital · 8d