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
73249–73272 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 14, 2003
DHS DISPOSABLE HOOD SYSTEM
K021992 · FYA
Biomet, Inc.
General Hospital · 210d
Cleared Jan 14, 2003
OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302
K022145 · DXE
LeMaitre Vascular, Inc.
Cardiovascular · 196d
Cleared Jan 14, 2003
ENDOSCOPIC LIGHT SOURCE XL180/L3
K023468 · GCT
World of Medicine Lemke GmbH
Gastroenterology & Urology · 90d
Cleared Jan 14, 2003
ULTROID HEMORRHOID MANAGEMENT SYSTEM
K023706 · KNS
Ultroid, LLC
Gastroenterology & Urology · 71d
Cleared Jan 14, 2003
RSV OIA
K023779 · GQG
Thermo Biostar, Inc.
Microbiology · 63d
Cleared Jan 14, 2003
HL888
K023834 · DXN
Health & Life Co., Ltd.
Cardiovascular · 57d
Cleared Jan 14, 2003
HEMOSIL FACTOR V DEFICIENT PLASMA
K023839 · GJT
Instrumentation Laboratory CO
Hematology · 57d
Cleared Jan 14, 2003
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT
K024126 · DQO
Abbott Laboratories
Cardiovascular · 29d
Cleared Jan 14, 2003
PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS,...
K024156 · DTD
Oscor, Inc.
Cardiovascular · 28d
Cleared Jan 14, 2003
CDS 3-PD HEMATOLOGY CONTROLS
K024173 · JPK
Clinical Diagnostic Solutions, Inc.
Hematology · 27d
Cleared Jan 14, 2003
POWDER-FREE COATED NITRILE EXAMINATION GLOVE, BLUE COLORED
K024184 · LZA
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 26d
Cleared Jan 13, 2003
TATUNG TMD-26AX SERIES TENS, MODELS NO. TMD-26AB TATUNG TENS (BLUE HOUSING)...
K021794 · GZJ
Tatung Co.
Neurology · 227d
Cleared Jan 13, 2003
BODY BOX 5500
K022636 · JEH
Morgan Scientific, Inc.
Anesthesiology · 158d
Cleared Jan 13, 2003
LIQUISHIELD-S (0.7G), MODEL LS 0010, LIQUISHIELD-S (2.0G), MODEL LS 0020
K023163 · KMF
Medlogic Global Limited
General & Plastic Surgery · 112d
Cleared Jan 13, 2003
MEDS-4 NEUROMUSCULAR STIMULATOR
K023435 · GZJ
Medical Equipment Device Specialists
Neurology · 90d
Cleared Jan 13, 2003
MEDS-4 NEUROMUSCULAR STIMULATOR
K023439 · IPF
Medical Equipment Device Specialists
Physical Medicine · 90d
Cleared Jan 13, 2003
MEDS-3 NEUROMUSCULAR STIMULATOR
K023443 · GZJ
Medical Equipment Device Specialists
Neurology · 90d
Cleared Jan 13, 2003
MEDS-3 NEUROMUSCULAR STIMULATOR
K023446 · IPF
Medical Equipment Device Specialists
Physical Medicine · 90d
Cleared Jan 13, 2003
NON-INVASIVE PATIENT FIXATION SYSTEM
K023449 · IYE
Stryker Leibinger
Radiology · 90d
Cleared Jan 13, 2003
DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES
K023459 · OLW
Datex-Ohmeda
Neurology · 90d
Cleared Jan 13, 2003
IMPULSE-ADJUSTING INSTRUMENT, CBP ADJUSTING INSTRUMENT, NEUROMECHANICAL...
K023462 · LXM
Neuromechanical Innovations, LLC
Physical Medicine · 90d
Cleared Jan 13, 2003
VIRIDIS TWIN OPHTHALMIC PHOTOCOAGULATOR
K023464 · GEX
Quantel Medical
General & Plastic Surgery · 90d
Cleared Jan 13, 2003
GOLD CORE PLUS
K023499 · EJH
Pentron Laboratory Technologies
Dental · 87d
Cleared Jan 13, 2003
LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET
K023572 · MVA
Rehabilitation Institute,Loma Linda...
Neurology · 81d