FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
88921–88944 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 21, 1998
3M TEGAGEN HI ALGINATE DRESSING & 3 M TEGAGEN HG ALGINATE DRESSING, MODEL #'S...
K982638 · QSY
Innovative Technologies , Ltd.
General & Plastic Surgery · 23d
Cleared Aug 21, 1998
CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1,...
K982845 · JJT
More Diagnostics
Chemistry · 9d
Cleared Aug 20, 1998
PTA BALLOON CATHETER
K980390 · LIT
Cook, Inc.
Cardiovascular · 199d
Cleared Aug 20, 1998
NPB3900 SERIES PATIENT MONITORS
K980411 · MHX
Analogic Corp.
Cardiovascular · 198d
Cleared Aug 20, 1998
SABRATEK PATIENT HOME MANAGEMENT SYSTEM
K980619 · MHX
Sabratek Corp.
Cardiovascular · 183d
Cleared Aug 20, 1998
PLAQ-ATAQ-I
K980995 · EFW
Ethicare
Dental · 174d
Cleared Aug 20, 1998
INTEGRATED DRIVE/PUMP SYSTEM
K981636 · HRX
Linvatec Corp.
Orthopedic · 104d
Cleared Aug 20, 1998
BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX
K981747 · DRS
Sunscope Intl., Inc.
Cardiovascular · 94d
Cleared Aug 20, 1998
VISAGE COSMETIC SURGERY SYSTEM
K981870 · GEI
Arthrocare Corp.
General & Plastic Surgery · 84d
Cleared Aug 20, 1998
AUTOCORR PLUS
K981939 · DQA
Bci Intl., Inc.
Anesthesiology · 79d
Cleared Aug 20, 1998
ULTIMA BODY POSITION SENSOR
K981969 · LEL
Braebon Medical Corp.
Neurology · 77d
Cleared Aug 20, 1998
THERMATREK IRIS-3 INFRARED IMAGING SYSTEM
K982112 · LHQ
Thermatrek, Inc.
Radiology · 65d
Cleared Aug 20, 1998
FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE
K982597 · KGN
Johnson & Johnson Medical, Inc.
General & Plastic Surgery · 27d
Cleared Aug 20, 1998
URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100,...
K982626 · EZL
Medworks Corp.
Gastroenterology & Urology · 23d
Cleared Aug 20, 1998
MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG)
K982755 · CAC
Medtronic Blood Management
Anesthesiology · 52d
Cleared Aug 19, 1998
FUTREX-6100/XL
K963271 · MNW
Futrex, Inc.
Gastroenterology & Urology · 729d
Cleared Aug 19, 1998
SIEMENS SEVOFLURANE VAPORIZER SV 953
K980884 · CAD
Siemens Medical Solutions USA, Inc.
Anesthesiology · 163d
Cleared Aug 19, 1998
KSEA ENDO TIP SYSTEM
K981130 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 142d
Cleared Aug 19, 1998
CARDIOVISION SOFTWARE, MODEL S-CV5-96
K981807 · DPS
Shl Telemedicine International , Ltd.
Cardiovascular · 90d
Cleared Aug 19, 1998
HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120##
K982289 · KNS
Olympus America, Inc.
Gastroenterology & Urology · 50d
Cleared Aug 19, 1998
PLATEX GENTLE GLIDE, SILK GLIDE, SLIMFITS, SOFT COMFORT AND PORTABLES TAMPONS
K982383 · HIL
Playtex Products, Inc.
Obstetrics & Gynecology · 42d
Cleared Aug 19, 1998
HICHEM CHOLESTEROL REAGENT KIT
K982469 · CHH
Elan Pharma, Inc.
Chemistry · 35d
Cleared Aug 19, 1998
SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT
K982608 · CKG
Sangui Biotech, Inc.
Chemistry · 23d
Cleared Aug 18, 1998
CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER
K980109 · KYX
Sangstat Medical Corp.
General Hospital · 218d