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
82585–82608 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 24, 2000
NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN
K000169 · EJR
Dentsply Intl.
Dental · 64d
Cleared Mar 24, 2000
HARDY DISK, PENICILLIN, 10 UNITS
K000302 · JTN
Hardy Diagnostics
Microbiology · 52d
Cleared Mar 24, 2000
BELLEGLASS HP TRANSLUCENT DENTIN
K000436 · EBF
Sybron Dental Specialties, Inc.
Dental · 43d
Cleared Mar 24, 2000
5F GUIDING CATHETER
K000598 · DQY
Guidant Corp.
Cardiovascular · 30d
Cleared Mar 24, 2000
THROMBOSTRATE CONTROL PLASMAS
K000679 · GGN
Pacific Hemostasis
Hematology · 24d
Cleared Mar 24, 2000
ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONFIGURATION, 6 THERAPY...
K000821 · FRN
Abbott Laboratories
General Hospital · 10d
Cleared Mar 24, 2000
TFX MEDICAL INTRODUCER ASSEMBLY
K993191 · DYB
Tfx Medical, Inc.
Cardiovascular · 183d
Cleared Mar 24, 2000
RUSCH MANUAL RESUSCITATOR BAG
K993194 · BTM
Rusch, Inc.
Anesthesiology · 183d
Cleared Mar 24, 2000
ULTICARE DISPOSABLE SYRINGE
K994230 · FMF
Ultimed, Inc.
General Hospital · 99d
Cleared Mar 24, 2000
ORTHO DEVELOPMENT BALANCED KNEE SYSTEM
K994370 · JWH
Ortho Development Corp.
Orthopedic · 88d
Cleared Mar 24, 2000
HDI 1500/SA 8800 ULTRASOUND SYSTEM WITH MULTIPLANE TRANSESOPHAGEAL ULTRASOUND...
K994373 · ITX
Atl Ultrasound, Inc.
Radiology · 88d
Cleared Mar 24, 2000
FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING
K994376 · DZE
Friadent GmbH
Dental · 88d
Cleared Mar 23, 2000
BELLEGLASS HP OPACEOUS DENTIN
K000269 · EBF
Sybron Dental Specialties, Inc.
Dental · 55d
Cleared Mar 23, 2000
REICHERT CT200 CONTACT TONOMETER
K000288 · HKY
Reichert Ophthalmic Instruments, Div....
Ophthalmic · 52d
Cleared Mar 23, 2000
PINNACLE ACETABULAR SYSTEM
K000306 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 51d
Cleared Mar 23, 2000
CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY
K000564 · FGE
Cordis Corp.
Gastroenterology & Urology · 30d
Cleared Mar 23, 2000
SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828
K000616 · MAI
Bionx Implants, Ltd.
Orthopedic · 28d
Cleared Mar 23, 2000
3S INJECTOR-CT CONTRAST DELIVERY SYSTEM
K983826 · DXT
Unimachs Corp.
Cardiovascular · 511d
Cleared Mar 23, 2000
PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP
K992174 · DXC
Pilling Weck Surgical
Cardiovascular · 269d
Cleared Mar 23, 2000
BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER
K993292 · MJN
Boston Scientific, Target
Cardiovascular · 174d
Cleared Mar 23, 2000
SEMI COMPLIANT (SC) 35 BALLOON DILATATION CATHETER
K993303 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 171d
Cleared Mar 23, 2000
SOLAR 7/8000
K993757 · DSI
General Electric Medical Systems...
Cardiovascular · 139d
Cleared Mar 23, 2000
NARKOMED 6000
K993826 · MLC
Draeger Medical, Inc.
Cardiovascular · 132d
Cleared Mar 23, 2000
EP MEDSYSTEMS, EP-WORKMATE
K994011 · DQK
Ep Medsystems, Inc.
Cardiovascular · 118d