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
72097–72120 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 2003
EVEREST BIPOLAR LYONS DISSECTING FORCEPS & GYRUS BIPOLAR LYONS DISSECTING...
K031080 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 42d
Cleared May 16, 2003
MODEL 4951M MYOCARDIAL UNIPOLAR LEAD
K031210 · DTB
Metronic, Inc.
Cardiovascular · 29d
Cleared May 16, 2003
MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS
K031218 · JDB
Tornier
Orthopedic · 29d
Cleared May 15, 2003
MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM
K022506 · MNR
Widemed, Ltd.
Anesthesiology · 289d
Cleared May 15, 2003
TENO FIX
K023594 · GAQ
Ortheon Medical, LLC
General & Plastic Surgery · 202d
Cleared May 15, 2003
MODIFICATION TO HORIZON SPINAL SYSTEM
K030840 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 59d
Cleared May 15, 2003
COLLAGEN TOPICAL WOUND DRESSING
K030921 · KGN
Collagen Matrix, Inc.
General & Plastic Surgery · 52d
Cleared May 15, 2003
PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH01
K030925 · GDW
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 52d
Cleared May 15, 2003
ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM
K030947 · JCT
Alveolus, Inc.
General & Plastic Surgery · 50d
Cleared May 15, 2003
SURGISIS NERVE CUFF
K031069 · JXI
Cook Biotech, Inc.
Neurology · 41d
Cleared May 15, 2003
BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM
K031295 · PAG
C.R. Bard, Inc.
Gastroenterology & Urology · 22d
Cleared May 15, 2003
BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH
K031332 · FTM
C.R. Bard, Inc.
General & Plastic Surgery · 17d
Cleared May 15, 2003
TPSA FLEX REAGENT CARTRIDGE
K031343 · LTJ
Dade Behring, Inc.
Immunology · 16d
Cleared May 14, 2003
COZART EIA COTININE URINE KIT
K021944 · MKU
Cozart Bioscience , Ltd.
Toxicology · 335d
Cleared May 14, 2003
COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR
K023733 · GEI
Ingenjorsfirman Bjorn Bergdahl AB
General & Plastic Surgery · 189d
Cleared May 14, 2003
L600 HAIR REMOVAL
K030480 · GEX
A&M Technology
General & Plastic Surgery · 90d
Cleared May 14, 2003
CAPIOX CARDIOTOMY RESERVOIR
K030505 · DPW
Terumo Cardiovascular Systems Corp.
Cardiovascular · 84d
Cleared May 14, 2003
DEPILASE TWIN YAG LASER SYSTEM
K030510 · GEX
Depilase Group , Ltd.
General & Plastic Surgery · 84d
Cleared May 14, 2003
GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM
K030512 · GCJ
Guidant Corp.
General & Plastic Surgery · 84d
Cleared May 14, 2003
HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE...
K030549 · DQX
Guidcorp
Cardiovascular · 82d
Cleared May 14, 2003
AQUASOFT (OCUFILCON D) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT,...
K030748 · LPL
Clearlab Pte , Ltd.
Ophthalmic · 65d
Cleared May 14, 2003
GEM
K030917 · BZG
Collins Medical, Inc.
Anesthesiology · 51d
Cleared May 14, 2003
CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1
K031086 · GWM
Integra Neurosciences
Neurology · 37d
Cleared May 14, 2003
CODMAN BACTISEAL BARIUM STRIPED CATHETERS
K031123 · HCA
Codman & Shurtleff, Inc.
Neurology · 35d