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
73345–73368 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 02, 2003
CERALAS D 980 LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT, MODEL: D15 AND D25
K024088 · GEX
Biolitec, Inc.
General & Plastic Surgery · 22d
Cleared Dec 31, 2002
NIGHTRON POLYSOMNOGRAPHY SYSTEM
K022249 · OLV
Telediagnostic Systems, Inc.
Neurology · 172d
Cleared Dec 31, 2002
PROFILE 1320 LASER SYSTEM
K022466 · GEX
Sciton, Inc
General & Plastic Surgery · 159d
Cleared Dec 31, 2002
BMC CATHETER CONNECTOR CABLE, MODEL RFP-101
K023334 · DSA
Baylis Medical Co., Inc.
Cardiovascular · 85d
Cleared Dec 31, 2002
SOVIS OPTIQUE'S ENDOSCOPIC CABLE
K023633 · FFS
Sovis Optique
Gastroenterology & Urology · 63d
Cleared Dec 31, 2002
ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391
K024084 · FRN
Abbott Laboratories
General Hospital · 20d
Cleared Dec 30, 2002
6.0 X 5.7MM DENTAL IMPLANT
K010185 · DZE
Bicon, Inc.
Dental · 710d
Cleared Dec 30, 2002
THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403),...
K020020 · GZJ
Well-Life Healthcare, Inc.
Neurology · 361d
Cleared Dec 30, 2002
3I IMPLANTS
K022009 · DZE
Implant Innovations, Inc.
Dental · 194d
Cleared Dec 30, 2002
BALDUR BRAND VINYL POWDER-FREE EXAMINATION GLOVES
K022091 · LYZ
Tangshan Zhonghong Pulin Group Co., Ltd.
General Hospital · 186d
Cleared Dec 30, 2002
CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING
K022584 · MGQ
Cardiotech Intl.
General & Plastic Surgery · 147d
Cleared Dec 30, 2002
ACELL UBM HYDRATED WOUND DRESSING
K022854 · KGN
Acell, Inc.
General & Plastic Surgery · 137d
Cleared Dec 30, 2002
ULTRA-LITE 200E LIGHT CURE UNIT
K023545 · EBZ
Rolence Ent., Inc.
Dental · 69d
Cleared Dec 30, 2002
SICKLE-CHEX SOLUBILITY KIT
K023656 · GHM
Streck Laboratories, Inc.
Hematology · 61d
Cleared Dec 30, 2002
PREPARE ADMINISTRATION SET
K023769 · FPA
Appro Healthcare, Inc.
General Hospital · 48d
Cleared Dec 30, 2002
ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELIVERY
K024032 · DQY
Medtronic Vascular
Cardiovascular · 24d
Cleared Dec 30, 2002
ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY
K024035 · DQY
Medtronic Vascular
Cardiovascular · 24d
Cleared Dec 30, 2002
NARROW ASCENT INTERLOK FEMORAL COMPONENTS
K024037 · JWH
Biomet, Inc.
Orthopedic · 24d
Cleared Dec 30, 2002
MODIFICATION TO CARDEON AEGIS CATHETER
K024058 · DWF
Cardeon Corp.
Cardiovascular · 21d
Cleared Dec 30, 2002
BD ULTRA-FINE III PEN NEEDLE
K024109 · FMI
Becton, Dickinson & CO
General Hospital · 17d
Cleared Dec 30, 2002
POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERILE
K024130 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 14d
Cleared Dec 27, 2002
PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY
K021987 · IXI
S&S Par Scientific
Radiology · 192d
Cleared Dec 27, 2002
NON-BIOABSORBABLE STAPLE
K023372 · NJU
Onux Medical, Inc.
General & Plastic Surgery · 80d
Cleared Dec 27, 2002
MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM
K023388 · JDR
Mitek Worldwide
Orthopedic · 79d