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
138817–138840 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 1987
STERILIZED OMNI GEL
K872519 · JOT
Echo Ultrasound
General & Plastic Surgery · 39d
Cleared Aug 03, 1987
HEARING-AID
K872552 · ESD
Audio-Technica U.S., Inc.
Ear, Nose, Throat · 35d
Cleared Aug 03, 1987
MICROMI-CK(TM)
K872598 · JHT
Intl. Immunoassay Laboratories, Inc.
Chemistry · 32d
Cleared Aug 03, 1987
SYNERGY
K872890 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 11d
Cleared Aug 03, 1987
DENTIN ADHESIVE
K872907 · EBF
Dentsply Intl.
Dental · 10d
Cleared Jul 31, 1987
SCALP VEIN SET
K870995 · FPA
Mac Lee Medical Products
General Hospital · 142d
Cleared Jul 31, 1987
GUSTILO/RAND TOTAL KNEE SYSTEM (GENESIS)
K871146 · JWH
Richards Medical Co., Inc.
Orthopedic · 130d
Cleared Jul 31, 1987
CAPTIA(R) TOXO-M: AN ENZYME IMMUNOASSAY
K871746 · LGD
Mercia Diagnostics , Ltd.
Microbiology · 87d
Cleared Jul 31, 1987
DRILL, HAND, BONE, SMEDBERG
K871834 · DZJ
Military Engineering, Inc.
Dental · 80d
Cleared Jul 31, 1987
ANCHOR IIA/2 STAGE OSSEO. TIT. 6/4 ALLOY IMPLANT
K871887 · DZE
Anchor Implants , Ltd.
Dental · 78d
Cleared Jul 31, 1987
PROBRIGHT TOOTH POLISHER
K871929 · JEQ
Lap Investments, Inc.
Dental · 74d
Cleared Jul 31, 1987
TEMPORARY BRIDGE HEAD
K871953 · DZE
Implant Innovations International, Inc.
Dental · 72d
Cleared Jul 31, 1987
ABUTMENT HEAD POST
K871954 · DZE
Implant Innovations International, Inc.
Dental · 72d
Cleared Jul 31, 1987
TEMPORARY SCREW
K871955 · DZE
Implant Innovations International, Inc.
Dental · 72d
Cleared Jul 31, 1987
BIRDIE BRACKET
K872028 · ISA
William W. Wilkerson & Gregory A....
Physical Medicine · 65d
Cleared Jul 31, 1987
RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDE
K872082 · LKT
Medical Diagnostic Technologies, Inc.
Microbiology · 63d
Cleared Jul 31, 1987
CURRETTES, ALVEOLAR (MOLT AND MILLER)
K872091 · EMS
Military Engineering, Inc.
Dental · 60d
Cleared Jul 31, 1987
CREMEEN ALVEOLAR BONE CALIPER
K872098 · EIL
Bowen & Company, Inc.
Dental · 60d
Cleared Jul 31, 1987
AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III
K872196 · JJS
American Dade
Chemistry · 53d
Cleared Jul 31, 1987
THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT
K872217 · GHM
Pacific Hemostasis
Hematology · 52d
Cleared Jul 31, 1987
MICROMEDIC COMBOSTAT LH/FSH KIT
K872309 · CGJ
Micromedic Systems
Chemistry · 45d
Cleared Jul 31, 1987
HEARING AID
K872348 · ESD
Assured Sound Laboratories, Inc.
Ear, Nose, Throat · 44d
Cleared Jul 31, 1987
BEHIND-THE-EAR HEARING AID OTICON E40
K872372 · ESD
Oticon Corp.
Ear, Nose, Throat · 42d
Cleared Jul 31, 1987
WIDEX HEARING AID MODEL ES1
K872374 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 42d