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
81025–81048 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 01, 2000
EQUIPMENT DRAPES
K002508 · KKX
Allegiance Healthcare Corp.
General Hospital · 17d
Cleared Aug 31, 2000
LIFE SCOPE EC, MODEL BSM-1102
K000517 · MHX
Nihon Kohden America, Inc.
Cardiovascular · 197d
Cleared Aug 31, 2000
SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR
K000700 · CCL
Sensidyne, Inc.
Anesthesiology · 183d
Cleared Aug 31, 2000
128 CHANNEL EEG HEADBOX, MODEL EX-NW-128
K000919 · GWQ
Excel Tech. , Ltd.
Neurology · 162d
Cleared Aug 31, 2000
GAZELLE BALLOON DILATATION CATHETER
K001134 · LIT
Boston Scientific Corp
Cardiovascular · 143d
Cleared Aug 31, 2000
IMPULSE SELECT
K001579 · NFB
Airsep Corp.
Anesthesiology · 101d
Cleared Aug 31, 2000
ATHOS
K001704 · GEX
Cosmos Medical Technology
General & Plastic Surgery · 87d
Cleared Aug 31, 2000
TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067
K001709 · JDQ
Pioneer Surgical Technology
Orthopedic · 87d
Cleared Aug 31, 2000
3D ACTIVETRAC
K001712 · ITH
The Saunders Group
Physical Medicine · 87d
Cleared Aug 31, 2000
RADIOLUCENT COLLES FRACTURE KIT
K001760 · LXT
Biomet, Inc.
Orthopedic · 83d
Cleared Aug 31, 2000
VASOTRAX
K001898 · DXN
Medwave, Inc.
Cardiovascular · 70d
Cleared Aug 31, 2000
OLEEVA FOAM
K002109 · MDA
Bio Med Sciences, Inc.
General & Plastic Surgery · 50d
Cleared Aug 31, 2000
LINEAGE ACETABULAR SYSTEM
K002149 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 45d
Cleared Aug 31, 2000
RD-2104
K002222 · EJT
J.F. Jelenko & Co., Inc.
Dental · 38d
Cleared Aug 31, 2000
BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220
K002333 · DRF
Biosense Webster, Inc.
Cardiovascular · 30d
Cleared Aug 31, 2000
M2A 28MM RINGLOC LINER
K002379 · KWA
Biomet, Inc.
Orthopedic · 27d
Cleared Aug 31, 2000
VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM
K002402 · HRX
Mitek Products
Orthopedic · 24d
Cleared Aug 31, 2000
VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM
K002422 · GEI
Mitek Products
General & Plastic Surgery · 23d
Cleared Aug 31, 2000
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS...
K002453 · LGD
Beckman Coulter, Inc.
Microbiology · 21d
Cleared Aug 31, 2000
LIQUICHEK LIPIDS CONTROL, MODEL 641, 642
K002460 · JJY
Bio-Rad
Chemistry · 21d
Cleared Aug 31, 2000
SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE...
K002528 · JBP
Sienco, Inc.
Hematology · 15d
Cleared Aug 31, 2000
ROTAFLOW CENTRIFUGAL PUMP SYSTEM
K991864 · KFM
Jostra Medizintechnik AG
Cardiovascular · 457d
Cleared Aug 31, 2000
PARALLAX CRANIOSET
K994022 · GXP
Parallax Medical, Inc.
Neurology · 279d
Cleared Aug 31, 2000
TORNIER BIPOLAR RADIAL HEAD PROSTHESIS
K994041 · KWI
Tornier, Inc.
Orthopedic · 276d