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
73297–73320 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 14, 2002
BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES
K022900 · JEQ
John O. Butler Co.
Dental · 72d
Cleared Nov 14, 2002
SILENTFLOW 2 EXHALATION SYSTEM, MODEL WM 23650
K022934 · BZD
Gottlieb Weinmann Geraete Fuer...
Anesthesiology · 71d
Cleared Nov 14, 2002
CARDIOTOUCH-3000
K023034 · LOS
Bionet Company, Ltd.
Cardiovascular · 63d
Cleared Nov 14, 2002
DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM
K023434 · LHQ
Dorex, Inc.
Radiology · 30d
Cleared Nov 14, 2002
FIXION INTERLOCKING PROXIMAL FEMUR INTRAMEDULLARY NAILING SYSTEM (FIXION PF...
K023437 · HSB
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 30d
Cleared Nov 14, 2002
SKINTACT ECG ELECTRODE
K023503 · DRX
Leonhard Lang GmbH
Cardiovascular · 27d
Cleared Nov 13, 2002
HEX-LOCK TEMPORARY ABUTMENT
K014050 · DZE
Sulzer Dental, Inc.
Dental · 338d
Cleared Nov 13, 2002
SCORPIO CR AND PS CO CR FEMORAL COMPONENTS WITH TITANIUM PLASMA SPRAY COATING
K020703 · JWH
Howmedica Osteonics Corp.
Orthopedic · 254d
Cleared Nov 13, 2002
FRESENIUS ICARE MONITORING SYSTEM
K021060 · FKP
Fresenius Medical Care North America
Gastroenterology & Urology · 225d
Cleared Nov 13, 2002
STELLAR SERIES SURGICAL LIGHTS WITH HERMES
K021585 · FSY
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 183d
Cleared Nov 13, 2002
MICROVASIVE PULMONARY GUIDEWIRE
K022059 · MDM
Boston Scientific Corp
General & Plastic Surgery · 141d
Cleared Nov 13, 2002
INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST
K022501 · DJC
Alfa Scientific Designs, Inc.
Toxicology · 107d
Cleared Nov 13, 2002
PHYSICAL MONITORING REGISTRATION UNIT
K022719 · IKN
Maryrose Cusimano, Ph.D./Phil Reaston
Neurology · 90d
Cleared Nov 13, 2002
AMT POLYAXIAL PEDICLE SCREW
K022768 · MNI
Micron Precision Engineering, Inc.
Orthopedic · 84d
Cleared Nov 13, 2002
LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION
K022769 · JJX
Bionostics, Inc.
Chemistry · 84d
Cleared Nov 13, 2002
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE COLOR
K022784 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 83d
Cleared Nov 13, 2002
SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM
K022791 · KWQ
Synthes (Usa)
Orthopedic · 83d
Cleared Nov 13, 2002
UNIVERSAL SYSTEM, MODEL QV-800
K023008 · KPR
Quantum Medical Imaging, LLC
Radiology · 65d
Cleared Nov 13, 2002
JIA CHEN ACUPUNCTURE NEEDLE, FOR SINGLE USE
K023054 · MQX
Mandala Health Care, LLC
General Hospital · 61d
Cleared Nov 13, 2002
MICRO-TOUCH NEXT STEP POWDER FREE MEDICAL EXAMINATION GLOVES WITH ALOE AND...
K023153 · LYY
Ansell Healthcare Products, Inc.
General Hospital · 51d
Cleared Nov 13, 2002
ORS-3000LD
K023282 · LHC
O.R. Solutions, Inc.
General Hospital · 43d
Cleared Nov 13, 2002
1075LD HUSH-SLUSH
K023283 · LHC
O.R. Solutions, Inc.
General Hospital · 43d
Cleared Nov 13, 2002
QUANTIX/ND DEVICE
K023431 · DPW
Cardiosonix, Ltd.
Cardiovascular · 29d
Cleared Nov 13, 2002
VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896
K023433 · MID
Pharmacia Diagnostics GmbH & Co. KG
Immunology · 29d