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
140281–140304 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 24, 1987
MODEL 102 PH METER
K870811 · LRI
Mesa Medical, Inc.
Gastroenterology & Urology · 21d
Cleared Mar 24, 1987
SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN AL
K870862 · MSJ
Atlantic Antibodies
Immunology · 21d
Cleared Mar 24, 1987
TINA-QUANT(R) (A) C3
K870930 · CZM
Boehringer Mannheim Corp.
Immunology · 15d
Cleared Mar 24, 1987
TINA-QUANT(R) (A) C4
K870931 · DBI
Boehringer Mannheim Corp.
Immunology · 15d
Cleared Mar 24, 1987
ABUSCREEN RADIOIMMUNOASSAY FOR BENZODIAZEPINES
K870994 · JXM
Roche Diagnostic Systems, Inc.
Toxicology · 13d
Cleared Mar 24, 1987
FUKUDA DENSHI MODEL FCP-15
K871025 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 8d
Cleared Mar 23, 1987
MODIFIED DRAGER SPHYGMOMED
K862427 · DXN
Draeger Medical, Inc.
Cardiovascular · 270d
Cleared Mar 23, 1987
COMPUTER EYE TRACKING SYS./ENG EXAM. CHAIR & TABLE
K863424 · GWN
Micromedical Technologies, Inc.
Neurology · 200d
Cleared Mar 23, 1987
7.5 MHZ SECTOR PROBE MODEL #GM-0317SS12
K863708 · ITX
Siemens Medical Solutions USA, Inc.
Radiology · 181d
Cleared Mar 23, 1987
HEART TRACK
K864293 · DXH
Cardio Telemetric Systems, Inc.
Cardiovascular · 143d
Cleared Mar 23, 1987
'EXMOOR' MOFFAT-ROBINSON BONE PATE COLLECTOR
K864938 · LRC
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 97d
Cleared Mar 23, 1987
CASSETTE TAPE REPLAY SYSTEM
K870554 · DSH
Research Instrumentation Associates,...
Cardiovascular · 41d
Cleared Mar 23, 1987
TIP, DENTAL SUCTION APPARATUS
K870599 · DYN
Military Engineering, Inc.
Dental · 41d
Cleared Mar 23, 1987
API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT(R)MIC
K870663 · JWY
Analytical Products, Inc.
Microbiology · 32d
Cleared Mar 23, 1987
NEW MODEL STYLES FOR AORTIC ARCH CANNULA
K870825 · DQR
Shiley, Inc.
Cardiovascular · 20d
Cleared Mar 23, 1987
ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN.
K870826 · DQR
Shiley, Inc.
Cardiovascular · 20d
Cleared Mar 23, 1987
TDK ECG ELECTRODE MEL-10
K870834 · DRX
Tdk Corp.
Cardiovascular · 20d
Cleared Mar 23, 1987
DISCIPLINE I
K870872 · ISD
Physio Systems, Inc.
Physical Medicine · 20d
Cleared Mar 23, 1987
LOOSE BODY GRASPERS
K870881 · HTD
Bowen & Company, Inc.
General & Plastic Surgery · 18d
Cleared Mar 23, 1987
45 DEGREE SHAVER
K870882 · HTZ
Bowen & Company, Inc.
General & Plastic Surgery · 18d
Cleared Mar 23, 1987
MT8 BIOLOGICAL TELEMETRY SYSTEM
K870901
Oxford Metrics, Inc.
Physical Medicine · 18d
Cleared Mar 23, 1987
'EXMOOR' T-TUBE
K871035 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 6d
Cleared Mar 23, 1987
SCMT UMBILICAL CLAMP
K871075 · HFW
Salt Creek Medical Technologies
Obstetrics & Gynecology · 5d
Cleared Mar 23, 1987
WINPETTE
K871076 · JPH
Ulster Scientific, Inc.
Hematology · 5d