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
153121–153144 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 1984
PROVIDER SITE PREP & CHECK STRIP KIT
K841027 · FPA
Pancretec, Inc.
General Hospital · 35d
Cleared Apr 13, 1984
C-PEPTIDE RADIOIMMUNOASSAY TEST KIT
K833396 · JKD
Serono Diagnostics, Inc.
Chemistry · 196d
Cleared Apr 13, 1984
THERMO SENTRY 1200 THERMO-SYS-TS1200
K833711 · FLL
Clini-Therm Corp.
General Hospital · 176d
Cleared Apr 13, 1984
PROVIDER U-100 INSULIN INFUSION SYS
K833983 · FRN
Pancretec, Inc.
General Hospital · 148d
Cleared Apr 13, 1984
CRITERION I
K834274 · CAW
Timeter Instrument Corp.
Anesthesiology · 127d
Cleared Apr 13, 1984
TECHNICARE 280
K834486 · IYO
Technicare Corp.
Radiology · 128d
Cleared Apr 13, 1984
HUMAN SERUM ELECTROLYTE CONTROL-LIQUID
K834505 · JJR
Quantimetrix Corp.
Chemistry · 114d
Cleared Apr 13, 1984
HEMODIAL CONCENTRATE
K834587 · FKQ
Moana Productions, Inc.
Gastroenterology & Urology · 106d
Cleared Apr 13, 1984
RHINOTHERM
K840118 · KFZ
Ascot Pharmaceuticals, Inc.
Anesthesiology · 93d
Cleared Apr 13, 1984
ESTIC MICROFILL
K840176 · EBF
Kulzer, Inc.
Dental · 87d
Cleared Apr 13, 1984
VISTECH VCTS 6000
K840255 · HOX
Vistech Consultants, Inc.
Ophthalmic · 81d
Cleared Apr 13, 1984
MULTIPLE BAG, LEG
K840283 · KNX
Luth Corp.
Gastroenterology & Urology · 86d
Cleared Apr 13, 1984
MULTIPLE SYS-URINE DRAINAGE-CLOSED
K840284 · KNX
Luth Corp.
Gastroenterology & Urology · 86d
Cleared Apr 13, 1984
CHEMONUCLEOLYSIS/DISCOGRAPHY TRAY
K840334 · FMI
Applied Medical Devices, Inc.
General Hospital · 79d
Cleared Apr 13, 1984
OVU STICK URINE HLH KIT
K840412 · CEP
Monoclonal Antibodies, Inc.
Chemistry · 73d
Cleared Apr 13, 1984
SUN-LITE ONE MILLIMETER
K840429
Suncoast Medical Manufacturers, Inc.
Ophthalmic · 73d
Cleared Apr 13, 1984
SUN-LITE 1
K840456
Suncoast Medical Manufacturers, Inc.
Ophthalmic · 71d
Cleared Apr 13, 1984
NORMAL CLINICAL CHEM. CONTROL SERUM-
K840457 · JJY
Otisville Biotech, Inc.
Microbiology · 71d
Cleared Apr 13, 1984
ISOSTAT MICROBIAL TUBE PROCESSING
K840496 · JKA
E.I. Dupont DE Nemours & Co., Inc.
Microbiology · 67d
Cleared Apr 13, 1984
HEMASTAPH
K840553 · JTL
Remel Co.
Microbiology · 65d
Cleared Apr 13, 1984
REX V
K840562 · EJH
Jeneric Ind.
Dental · 65d
Cleared Apr 13, 1984
MULTI-STIMT
K840599 · GZJ
Joanco Medical Electronics , Ltd.
Neurology · 63d
Cleared Apr 13, 1984
LABORIE FIBREOPTIC LIGHT CABLE
K840605 · FFS
Tridak Division of Indicon, Inc.
Gastroenterology & Urology · 63d
Cleared Apr 13, 1984
RIFAMPIN DISC
K840614 · JTO
Remel Co.
Microbiology · 60d