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
167281–167304 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 1980
CULTURIA MACCONKEY/CLED #DM87
K800215 · JXA
Clinical Convenience Products, Inc.
Microbiology · 9d
Cleared Feb 13, 1980
SEROCLUSTER U AND V
K800240 · JTC
Corning Costar Corp.
Microbiology · 8d
Cleared Feb 11, 1980
AMP DIRECT VASCULAR MONITORING SYSTEM
K792646 · KRH
American Medical Products, Inc.
Cardiovascular · 52d
Cleared Feb 11, 1980
COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE
K792669 · HGP
Ge Medical Systems Information...
Obstetrics & Gynecology · 46d
Cleared Feb 11, 1980
MODEL 807 SUCTION CAUTERY FINGER TIP
K800022 · GEI
Malibu Laboratories
General & Plastic Surgery · 35d
Cleared Feb 11, 1980
MICRO ELISA MINI READER
K800057 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 32d
Cleared Feb 11, 1980
PIPET CALIBRATION KIT
K800062 · JIS
Streck Laboratories, Inc.
Chemistry · 31d
Cleared Feb 11, 1980
COMBISON 100-MODEL 100 & 110
K800091 · IYO
Kt Medical, Inc.
Radiology · 28d
Cleared Feb 11, 1980
TRANSDUCER
K800093
Kt Medical, Inc.
Cardiovascular · 28d
Cleared Feb 11, 1980
COMBISON 200 & COMBISON 202
K800094 · IYO
Kt Medical, Inc.
Radiology · 28d
Cleared Feb 11, 1980
MGD-3
K800095 · KNG
Kt Medical, Inc.
Obstetrics & Gynecology · 28d
Cleared Feb 11, 1980
AMBIVASON DR-200
K800096 · JAF
Kt Medical, Inc.
Radiology · 28d
Cleared Feb 11, 1980
MINIVASON 9
K800097 · JAF
Kt Medical, Inc.
Radiology · 28d
Cleared Feb 11, 1980
MINIFETON 200
K800098 · KNG
Kt Medical, Inc.
Obstetrics & Gynecology · 28d
Cleared Feb 11, 1980
TELESONIC (HEARING AID)
K800105 · ESD
Telesonic, Inc.
Ear, Nose, Throat · 26d
Cleared Feb 11, 1980
SEARS BEHIND-THE-EAR HEARING AID
K800113 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 26d
Cleared Feb 11, 1980
TRU-PULSE PADS
K800117 · GXY
Ipco Corp.
Neurology · 24d
Cleared Feb 11, 1980
CENTRIFICHEM ALP/ALKALINE PHOSPHATASE
K800131 · CJE
Union Carbide Corp.
Chemistry · 24d
Cleared Feb 11, 1980
SEARLE PHO/SONIC ALPHA 2000
K800139 · IYO
G.D. Searle and Co.
Radiology · 21d
Cleared Feb 11, 1980
ONCE TM
K800162 · HDW
G.D. Searle and Co.
Obstetrics & Gynecology · 17d
Cleared Feb 11, 1980
I.M. BLADES
K800177 · GDX
Instrument Makar, Inc.
General & Plastic Surgery · 14d
Cleared Feb 11, 1980
INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR
K800179 · DXW
Sphygmetrics, Inc.
Cardiovascular · 13d
Cleared Feb 11, 1980
OXFORD EXTERNAL FIXATION SYSTEM
K800184 · JEC
Downs Surgical , Ltd.
Orthopedic · 13d
Cleared Feb 11, 1980
OVALITH P-BP BIPOLAR CARDIAC PACEMAKER
K800194 · DXY
Coratomic, Inc.
Cardiovascular · 13d