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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
101113–101136 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 06, 1995
URINARY METANEPHRINE KIT
K952919 · CHQ
Bioanalytical Systems, Inc.
Chemistry · 72d
Cleared Sep 06, 1995
ACETAMINOPHEN ASSAY
K952949 · LDP
Diagnostic Chemicals , Ltd.
Toxicology · 72d
Cleared Sep 06, 1995
KARL STORZ ENT SHAVER
K953370 · EQJ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 50d
Cleared Sep 06, 1995
CRONEX RADIATION THERAPY CASSETTE
K953724 · IXA
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 27d
Cleared Sep 06, 1995
CRONEX RADIATION THERAPY VERIFICATION CASSETTE
K953725 · IXA
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 27d
Cleared Sep 06, 1995
PRISM ELECTROSCOPE
K953849 · EOX
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 21d
Cleared Sep 06, 1995
HICHEM ISE DILUENT KIT 70008
K953860 · CGZ
Hichem Diagnostics
Chemistry · 20d
Cleared Sep 06, 1995
HICHEM ISE INTDERNAL REFERENCE KIT 70009
K953861 · CGZ
Hichem Diagnostics
Chemistry · 20d
Cleared Sep 06, 1995
HICHEM ISEKCI SOLUTION KIT 70010
K953862 · CGZ
Hichem Diagnostics
Chemistry · 20d
Cleared Sep 06, 1995
HICHEM ISE STANDARDS KIT 70011
K953863 · JIX
Hichem Diagnostics
Chemistry · 20d
Cleared Sep 05, 1995
FLUOROSCAN NEONATAL
K950415 · KHO
Isolab, Inc.
Chemistry · 217d
Cleared Sep 05, 1995
ELSA-HCT
K951708 · JKR
Cis-Us, Inc.
Chemistry · 145d
Cleared Sep 05, 1995
COVER GOWN
K952116 · FYC
American Threshold Industries, Inc.
General Hospital · 123d
Cleared Sep 05, 1995
BIOSCAN
K952307 · JIL
Biosys Laboratories, Inc.
Chemistry · 111d
Cleared Sep 05, 1995
SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER
K952560 · JPA
Sienco, Inc.
Hematology · 95d
Cleared Sep 05, 1995
QUALICHECK 4 GLUCOSE
K952637 · JJS
Radiometer America, Inc.
Chemistry · 88d
Cleared Sep 05, 1995
AMPRI
K952833 · LYY
Ampri Rubberware Industries Sdn Bhd
General Hospital · 77d
Cleared Sep 05, 1995
PRO-LOCK
K952857 · DYH
Midwest Orthodontic Mfg.
Dental · 75d
Cleared Sep 05, 1995
LIGHT-CURE
K952858 · DYH
Midwest Orthodontic Mfg.
Dental · 75d
Cleared Sep 05, 1995
MODEL A15-101
K953191 · EAY
Beaverstate Dental, Inc.
Dental · 74d
Cleared Sep 05, 1995
MODEL A15-103
K953192 · EAY
Beaverstate Dental, Inc.
Dental · 74d
Cleared Sep 05, 1995
MERTEX-PLUS O.R./SURGEONS GOWN
K953251 · FYA
Mercana Industries , Ltd.
General Hospital · 55d
Cleared Sep 05, 1995
LABORATORY SUPPLIES
K953380 · DZE
Steri-Oss, Inc.
Dental · 48d
Cleared Sep 05, 1995
SEEK
K953526 · LFC
Ultradent Products, Inc.
Dental · 40d