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
85705–85728 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 21, 1999
SURGEON'S GLOVES
K984395 · KGO
Sri Anusham Rubber Industries Pvt., Ltd.
General Hospital · 164d
Cleared May 21, 1999
BAYER ADVIA 1650 CHEMISTRY SYSTEM
K990346 · JGS
Bayer Corp.
Chemistry · 106d
Cleared May 21, 1999
SONOTOME
K990572 · LFL
Sonokinetics, Inc.
General & Plastic Surgery · 87d
Cleared May 21, 1999
BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE)
K990878 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 66d
Cleared May 21, 1999
LAGLOVE BRAND COLORED NITRILE EXAMINATION GLOVES (POWDER FREE)
K990882 · LZA
La Glove (M) Sdn. Bhd.
General Hospital · 66d
Cleared May 21, 1999
EASYSAFE RETRACTING NEEDLE SYRINGE
K991039 · FMF
Saf-T-Med, Inc.
General Hospital · 53d
Cleared May 21, 1999
SMARTEMP
K991270 · EBG
Parkell, Inc.
Dental · 38d
Cleared May 21, 1999
POWDER-FREE LATEX SURGEON'S GLOVE SAFESKIN PFS PLUS CONTAINS 50MLGM OR LESS...
K991317 · KGO
Safeskin Corp.
General Hospital · 32d
Cleared May 21, 1999
ASCENT KNEE SYSTEM
K991428 · JWH
Biomet, Inc.
Orthopedic · 25d
Cleared May 21, 1999
MICROGAS 7650 TRANSCUTANEOUS MONITOR
K991644 · KLK
Linde Medical Sensors AG
Anesthesiology · 8d
Cleared May 21, 1999
CENTRAFIX EXTERNAL FIXATOR
K991732 · JEC
Owandar Medical, Ltd.
Orthopedic
Cleared May 20, 1999
WRIST BLOOD PRESSURE METER MODEL SE-330
K973078 · DPW
Sein Electronics Co., Ltd.
Cardiovascular · 640d
Cleared May 20, 1999
WALKCARE P200 SYSTEM
K973592 · JOW
A.Stein - Regulatory Affairs Consulting
Cardiovascular · 605d
Cleared May 20, 1999
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)
K983840 · HGI
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 202d
Cleared May 20, 1999
VAPO-SOLUTION FOR USE IN MDT HARVEY CHEMICLAVE STERILIZERS, MODELS 5000,...
K984270 · MED
Roger L. Goodman, D.D.S., P.C.
General Hospital · 171d
Cleared May 20, 1999
IODINE BRACHYTHERAPY SEEDS, MODEL 3000
K990193 · KXK
Implant Sciences Corp.
Radiology · 119d
Cleared May 20, 1999
LIFE IMAGING SYSTEMS, MODEL L3DI
K990560 · IYO
Life Imaging Systems, Inc.
Radiology · 87d
Cleared May 20, 1999
POLYMER COATED POWDERFREE LATEX EXAMINTATION GLOVES
K990690 · LYY
Top Glove Sdn. Bhd.
General Hospital · 78d
Cleared May 20, 1999
BARRIERPLUS SYNTHETIC POWDER-FREE SURGICAL GLOVES
K990710 · KGO
Barriermed Glove Co.
General Hospital · 77d
Cleared May 20, 1999
TRU-CORE I REUSABLE BIOPSY INSTRUMENT
K990839 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 66d
Cleared May 20, 1999
EXTRA LARGE BODY COIL FOR OPART (MRT-600)
K991057 · MOS
Toshiba America Mri, Inc.
Radiology · 51d
Cleared May 20, 1999
VITRON H
K991220 · EBI
Espe Dental AG
Dental · 38d
Cleared May 20, 1999
VESTOGUM
K991221 · ELW
Espe Dental AG
Dental · 38d
Cleared May 20, 1999
AII-PRO 100 PLUS AND ALL-PRO 200
K991435 · IXW
All-Pro Imaging Corp.
Radiology · 24d