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
72337–72360 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 2003
GC OIA
K023947 · LIR
Thermo Biostar, Inc.
Microbiology · 141d
Cleared Apr 17, 2003
2 BASIC
K030175 · IYE
Capintec, Inc.
Radiology · 90d
Cleared Apr 17, 2003
LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DESENSITIZING...
K030176 · HIS
Suretex, Ltd.
Obstetrics & Gynecology · 90d
Cleared Apr 17, 2003
INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM
K030181 · GEX
International Biophysics Corp.
General & Plastic Surgery · 90d
Cleared Apr 17, 2003
COULTER ACT 5DIFF AUTOLOADER (AL)
K030291 · GKZ
Beckman Coulter, Inc.
Hematology · 79d
Cleared Apr 17, 2003
ARTHROSCOPY PUMP, MODEL A107
K030402 · HRX
W.O.M. World of Medicine AG
Orthopedic · 70d
Cleared Apr 17, 2003
OPHTEC ENCLAVATION NEEDLE
K030471 · HNQ
Ophtec, USA
Ophthalmic · 64d
Cleared Apr 17, 2003
HL888HM
K030499 · DXN
Health & Life Co., Ltd.
Cardiovascular · 57d
Cleared Apr 17, 2003
RIVA-SELF CURE
K030516 · EMA
Southern Dental Industries, Inc.
Dental · 57d
Cleared Apr 17, 2003
ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME...
K030533 · LCX
Cenogenics Corp.
Chemistry · 62d
Cleared Apr 17, 2003
VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100
K030613 · MHX
Criticare Systems, Inc.
Cardiovascular · 50d
Cleared Apr 17, 2003
ANMP (ACOUSTIC NEURO MODULATION PROTOCOL)
K030791 · KLW
Tinnitech, Ltd.
Ear, Nose, Throat · 36d
Cleared Apr 17, 2003
MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG...
K030855 · KNT
Boston Scientific Corp
Gastroenterology & Urology · 30d
Cleared Apr 17, 2003
BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR
K030862 · MNI
Blackstone Medical, Inc.
Orthopedic · 30d
Cleared Apr 17, 2003
POWDERED VINYL EXAM GLOVES, WHITE
K030927 · LYZ
Copioumed Intl., Inc.
General Hospital · 24d
Cleared Apr 17, 2003
GE LOGIQ 9 MODEL 2375600
K030934 · IYN
Ge Medical Systems, Inc.
Radiology · 23d
Cleared Apr 17, 2003
INFINTT CO., LTD. STARPACS SYSTEM
K031013 · LLZ
Infinitt Company
Radiology · 17d
Cleared Apr 16, 2003
PANCREATIC DRAINAGE TUBE
K021672 · FGE
Aomori Olympus Co., Ltd.
Gastroenterology & Urology · 330d
Cleared Apr 16, 2003
A/T X-RAY 70
K024285 · EHD
Air Techniques, Inc.
Radiology · 114d
Cleared Apr 16, 2003
THERMATREK IRIS-IV INFRARED IMAGING SYSTEM
K030165 · LHQ
Thermatrek
Radiology · 90d
Cleared Apr 16, 2003
IMBIBE II SYRINGE
K030208 · FMF
Orthovita, Inc.
General Hospital · 85d
Cleared Apr 16, 2003
HTS ARRAY COIL
K030540 · MOS
Jockey Club Mri Engineering Center
Radiology · 55d
Cleared Apr 16, 2003
PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400
K030854 · FCX
E-Z-Em, Inc.
Gastroenterology & Urology · 29d
Cleared Apr 16, 2003
ARTHROCARE PERCD SPINEWAND
K030954 · GEI
Arthrocare Corp.
General & Plastic Surgery · 20d