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
72049–72072 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 2003
STANDARD THERMOMETER
K030658 · FLL
Global Treasure Industries , Ltd.
General Hospital · 22d
Cleared Mar 25, 2003
BONE WIRE
K030665 · HTY
Stork Instrumente GmbH
Orthopedic · 22d
Cleared Mar 25, 2003
MULTICARE PLATINUM SYSTEM AND ACCESSORIES
K030666 · IZH
Lorad, A Hologic Co.
Radiology · 22d
Cleared Mar 24, 2003
SYNTHES USS, CLICK'X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS
K022949 · MNI
Synthes (Usa)
Orthopedic · 200d
Cleared Mar 24, 2003
MODIFICATION TO PLEXOLONG SETS
K023218 · BSP
Pajunk GmbH
Anesthesiology · 179d
Cleared Mar 24, 2003
LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT
K024301 · ODC
Lsi Solutions
Gastroenterology & Urology · 90d
Cleared Mar 24, 2003
NMA 1052 CONSOLE SYSTEM WITH NMA 100 LASER ACCESSORY
K024310 · NHN
Medx Electronics, Inc.
Physical Medicine · 90d
Cleared Mar 24, 2003
AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER
K024349 · HCH
Aesculap, Inc.
Neurology · 84d
Cleared Mar 24, 2003
XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT
K030194 · KNS
The Olympus Optical Co.
Gastroenterology & Urology · 62d
Cleared Mar 24, 2003
BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT
K030238 · DBM
The Binding Site, Ltd.
Immunology · 60d
Cleared Mar 24, 2003
MODIFICATION TO VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTRILLED...
K030567 · JCT
Vascular Architects, Inc.
General & Plastic Surgery · 28d
Cleared Mar 24, 2003
MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM
K030611 · MNR
Nellcor Puritan Bennett (Melville) ,...
Anesthesiology · 26d
Cleared Mar 21, 2003
IQTEQ SPIROMETER
K020102 · BZG
Iqteq Development
Anesthesiology · 434d
Cleared Mar 21, 2003
STIMUPLEX-DIG-RC NERVE STIMULATOR
K021033 · BXN
B.Braun Medical, Inc.
Anesthesiology · 357d
Cleared Mar 21, 2003
ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452
K022198 · GWG
Richard Wolf Medical Instruments Corp.
Neurology · 259d
Cleared Mar 21, 2003
PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS
K022212 · JOH
Mentor Medical Limited
Anesthesiology · 256d
Cleared Mar 21, 2003
MODIFICATION TO NASAL-AIRE
K022465 · BZD
Innomed Technologies
Anesthesiology · 238d
Cleared Mar 21, 2003
POWDER-FREE RADIATION ATTENUATING NEOPRENE SURGICAL GLOVE (BLACK)
K022873 · KGO
International Biomedical, Inc.
General Hospital · 204d
Cleared Mar 21, 2003
BPTRU VITAL SIGNS MONITOR, MODEL BPM-300, & BPTRU PORTABLE AUTOMATED...
K023078 · DXN
Vsm Medtech , Ltd.
Cardiovascular · 186d
Cleared Mar 21, 2003
CHROMOPHARE X 65
K024132 · FSY
Berchtold Holding GmbH
General & Plastic Surgery · 95d
Cleared Mar 21, 2003
CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
K024260 · GEX
Candela Corp.
General & Plastic Surgery · 88d
Cleared Mar 21, 2003
ACRYLIC
K024282 · EBG
Inovativ, LLC
Dental · 88d
Cleared Mar 21, 2003
FIXOBRIDGE 3-CEMENT
K024287 · EMA
Advanced Healthcare , Ltd.
Dental · 88d
Cleared Mar 21, 2003
JI-EE ELECTRIC SCOOTER, ELEGANCE ES 3
K024329 · INI
Ji-Ee Industry Co., Ltd.
Physical Medicine · 85d