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
86041–86064 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 14, 1999
HEADED BIO-ABSORBABLE CORKSCREW MODEL #AR-1921BU
K990361 · MAI
Arthrex, Inc.
Orthopedic · 68d
Cleared Apr 14, 1999
SMITH & NEPHEW HANDPORT SYSTEM
K990414 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 63d
Cleared Apr 14, 1999
DERMACOOL
K990417 · GEX
Optomed Corp.
General & Plastic Surgery · 63d
Cleared Apr 14, 1999
INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1
K990594 · DER
Roche Diagnostics Corp.
Chemistry · 49d
Cleared Apr 14, 1999
INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B
K990595 · DFC
Roche Diagnostics Corp.
Chemistry · 49d
Cleared Apr 14, 1999
OXYCON LENS
K990895 · HQD
Concise Contact Lens Co.
Ophthalmic · 28d
Cleared Apr 14, 1999
MODIFICATION OF: EBI SPINELINK SYSTEM
K990999 · MAI
Electro-Biology, Inc.
Orthopedic · 20d
Cleared Apr 14, 1999
NELLCOR PURITAN BENNETT, GOODKNIGHT 418G
K991150 · BZD
Nellcor Puritan Bennett France Dvpt.
Anesthesiology · 8d
Cleared Apr 13, 1999
UNI-FLEX RESIN
K983461 · EBI
Trans-Atlantic Dental
Dental · 194d
Cleared Apr 13, 1999
COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT...
K983892 · JPA
Roche Diagnostics/Boehringer Mannheim...
Hematology · 161d
Cleared Apr 13, 1999
HOLTER 2000
K990170 · MLO
Zymed Medical Instrumentation
Cardiovascular · 84d
Cleared Apr 13, 1999
TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT...
K990172 · GKZ
Coulter Corp.
Hematology · 84d
Cleared Apr 13, 1999
WILTEK HOT BIOPSY FORCEPS
K990231 · KGE
Wiltek Medical, Inc.
Gastroenterology & Urology · 78d
Cleared Apr 13, 1999
BARRIER SURGICAL GOWNS
K990395 · FYA
Johnson & Johnson Medical, Div. of...
General Hospital · 63d
Cleared Apr 13, 1999
ONTRAK TESTCUP-ER M2K
K990418 · DKZ
Roche Diagnostics Corp.
Toxicology · 62d
Cleared Apr 13, 1999
HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE
K990449 · JPA
International Technidyne Corp.
Hematology · 60d
Cleared Apr 13, 1999
CODAN CHEMOSPIKE
K990711 · LHI
Codan US Corp.
General Hospital · 40d
Cleared Apr 13, 1999
MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15
K990845 · KWP
Advanced Spine Fixation Systems, Inc.
Orthopedic · 29d
Cleared Apr 13, 1999
MODIFICATION TO IMTEC SENDAX MDI
K990983 · DZE
Imtec Corp.
Dental · 20d
Cleared Apr 12, 1999
AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD
K982722 · CAF
Ambu, Inc.
Anesthesiology · 250d
Cleared Apr 12, 1999
CARDIAC DIAGNOSTIC SYSTEM MODEL CH 2000
K983102 · DQK
Cambridge Heart, Inc.
Cardiovascular · 221d
Cleared Apr 12, 1999
LTV 1000
K984056 · CBK
Pulmonetic Systems, Inc.
Anesthesiology · 150d
Cleared Apr 12, 1999
PVR-100/VASOGRAM
K990123 · JOM
Vasocor, Inc.
Cardiovascular · 89d
Cleared Apr 12, 1999
TL250 INTERFERENTIAL/MUSCLE STIMULATOR INTERFERENTIAL CURRENT THERAPY...
K990129 · LIH
Therapy Link, Inc.
Neurology · 89d