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
151417–151440 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 27, 1984
ARGYLE CUSTOM TUBING PACK
K842889 · DWF
Sherwood Medical Co.
Cardiovascular · 35d
Cleared Aug 27, 1984
KEMBLE 405
K842894 · JQW
Kemble Instruments, Inc.
Chemistry · 35d
Cleared Aug 27, 1984
WBA - I.R.I.S.
K842895 · JAM
Siemens Gammasonics, Inc.
Radiology · 35d
Cleared Aug 27, 1984
LASER RECTOSCOPE SET 784
K842997 · FDC
Laser Industries , Ltd.
Gastroenterology & Urology · 28d
Cleared Aug 27, 1984
TOTAL PROTEIN ASSAY KIT
K843028 · CEK
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 26d
Cleared Aug 27, 1984
HIGH DENSITY LIPOPROTEIN PRECIPITATIN
K843029 · LBS
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 26d
Cleared Aug 27, 1984
INORGANIC PHOSPHORUS ASSAY KIT
K843030 · CEO
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 26d
Cleared Aug 27, 1984
MAGNESIUM ASSAY KIT
K843031 · JGJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 26d
Cleared Aug 27, 1984
UREA ASSAY KIT
K843057 · CDQ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 24d
Cleared Aug 27, 1984
SYSTEMATE CREATININE 67223
K843105 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 20d
Cleared Aug 27, 1984
SYSTEMATE TRIGLYCERIDE 67219
K843106 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 20d
Cleared Aug 27, 1984
SYSTEMATE TOTAL PROTEIN 67218
K843107 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 20d
Cleared Aug 27, 1984
SYSTEMATE ALBUMIN
K843108 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 20d
Cleared Aug 27, 1984
KODAK T-MAT H FILM SO-118
K843148 · LWZ
Eastman Kodak Company
Cardiovascular · 17d
Cleared Aug 27, 1984
KODAK T-MAT C FILM SO-119
K843149 · LWZ
Eastman Kodak Company
Radiology · 17d
Cleared Aug 27, 1984
SYSTEMATE GLUCOSE 67216
K843150 · CFR
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Aug 27, 1984
SYSTEMATE GLUCOSE 67215
K843151 · CGA
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Aug 27, 1984
KODAK X-OMATIC RADIATION THERAPY CASS
K843176 · IXA
Eastman Kodak Company
Radiology · 14d
Cleared Aug 24, 1984
CPR LOCATOR
K833737 · LIX
Lifepoint,Inc
Cardiovascular · 304d
Cleared Aug 24, 1984
CLINI-TEK AUTO 2000 REFLECTANCE SPECTR
K841041 · KQO
Miles Laboratories, Inc.
Chemistry · 165d
Cleared Aug 24, 1984
BP800, 850 1000
K841095 · DXN
Associated Mills, Inc.
Cardiovascular · 164d
Cleared Aug 24, 1984
MICRO FLUID APPLICATOR
K841357 · JZF
Treace Medical, Inc.
Ear, Nose, Throat · 144d
Cleared Aug 24, 1984
INTERMITTENT URETHRAL CATHETER TRAY
K841769 · KOD
Seamless Hospital Products Co.
Gastroenterology & Urology · 116d
Cleared Aug 24, 1984
CUSTOM STERILE PROCEDURE TRAYS-MULTI
K841850
Sterilco, Inc.
General & Plastic Surgery · 113d