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
112849–112872 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 08, 1993
RESILIENCE ORTHODONTIC BRACKET ADHES W/BOND RESINS
K925359 · DYH
Confi-Dental Products Co.
Dental · 259d
Cleared Jul 08, 1993
DAVIS+GECK ABSORBABLE LIGATING DEVICE
K925602 · GCJ
Davis & Geck, Inc.
General & Plastic Surgery · 245d
Cleared Jul 08, 1993
READAR/SUSCEPTIBILITY, GRAM NEGATIVE PANELS
K925859 · LRG
Alamar Biosciences, Inc.
Microbiology · 233d
Cleared Jul 08, 1993
ASI LIGASURE(TM) SUTURE LIGATION INSTRUMENT
K926110 · GCJ
Advanced Surgical Intervention, Inc.
General & Plastic Surgery · 217d
Cleared Jul 08, 1993
POSICAM-HZ & POSICAM-HZL
K926206 · KPS
Positron
Radiology · 211d
Cleared Jul 08, 1993
THERASNORE
K926382 · LRK
Dr. Thomas E. Meade
Dental · 198d
Cleared Jul 08, 1993
SWEEN WOUND CARE-COLLAGEN WOUND DRESSING
K926389 · MGQ
Sween Corp.
General & Plastic Surgery · 198d
Cleared Jul 08, 1993
MODEL 322 CLINICAL AUDIOMETER
K930203 · EWD
Virtual Corp.
Ear, Nose, Throat · 175d
Cleared Jul 08, 1993
SOLO TIES
K930452 · EJF
Zulaf, Inc.
Dental · 162d
Cleared Jul 08, 1993
MPM HYDROGEL SATURATED DRESSING
K930560 · MGQ
Mpm Medical., Inc.
General & Plastic Surgery · 155d
Cleared Jul 08, 1993
UROLOGICAL CATHETER & ACCESSORIES
K930882 · FAD
Applied Medical Resources
Gastroenterology & Urology · 139d
Cleared Jul 08, 1993
DAVIS+GECK VALTRAC BIOFRAG ANASTOMOSIS RING
K931056 · GDW
American Cyanamid Co.
General & Plastic Surgery · 129d
Cleared Jul 08, 1993
THE VP500 EPILATOR
K931062 · KCW
Instantron
General & Plastic Surgery · 129d
Cleared Jul 08, 1993
THE ELITE EPILATOR
K931063 · KCW
Instantron
General & Plastic Surgery · 129d
Cleared Jul 08, 1993
THE BLENDTONE EPILATOR
K931064 · KCW
Instantron
General & Plastic Surgery · 129d
Cleared Jul 08, 1993
AS3000 OPERATIVE DENTAL UNIT (DELIVERY SYSTEM)
K931204 · EIA
Den-Tal-Ez Mfg Co., Inc.
Dental · 121d
Cleared Jul 08, 1993
VARIGLASS VLC GLASS IONOMER
K931229 · EMA
Dentsply Intl.
Dental · 120d
Cleared Jul 08, 1993
ACETASITE
K931257 · LDP
Gds Diagnostics
Toxicology · 118d
Cleared Jul 08, 1993
ARGELITE 55
K931475 · EJT
Argen Precious Metals, Inc.
Dental · 106d
Cleared Jul 08, 1993
HYDRASORB STERILE DRESSING
K931599 · MGP
Calgon Vestal Div.
General & Plastic Surgery · 98d
Cleared Jul 08, 1993
NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL
K931663 · EJF
Ortho Organizers, Inc.
Dental · 94d
Cleared Jul 08, 1993
NEW DENTINE ADHESIVE
K931812 · KLE
Dentsply Intl.
Dental · 87d
Cleared Jul 08, 1993
DENTHESIVE II
K931838 · KLE
Heraeus Kulzer, Inc.
Dental · 86d
Cleared Jul 08, 1993
PROFILL LC COMPOSITE
K931880 · EBF
Jedental Co., Inc.
Dental · 85d