FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
126145–126168 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 1990
SPECIAL BOND
K901916 · EBF
Ivoclar North America, Inc.
Dental · 57d
Cleared Jun 22, 1990
CONTACT MOLAR BANDS AND CONTOUR STRIPS
K901919 · DZN
Ivoclar North America, Inc.
Dental · 57d
Cleared Jun 22, 1990
VKS-1 VIDEO KERATOSCOPE
K902012 · HLQ
Computed Anatomy, Inc.
Ophthalmic · 50d
Cleared Jun 22, 1990
LATEX EXAMINATION GLOVES
K902459 · LYY
Yue XI State Farms Latex Products...
General Hospital · 18d
Cleared Jun 22, 1990
WEEVAC 6 INFANT EVACUATION STRETCHER
K902521 · FPP
W. Murphy Ent., Inc.
General Hospital · 15d
Cleared Jun 22, 1990
GRI LASERGRAPH(TM) ECG PAPER
K902586 · DSF
Gri Medical Products, Inc.
Cardiovascular · 10d
Cleared Jun 21, 1990
PLASMA TFE VASCULAR PROSTHESIS MODIFIED INSTRUC.
K896964 · DSY
Medtronic Vascular
Cardiovascular · 188d
Cleared Jun 21, 1990
SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO
K897141 · JDN
Stuart
Orthopedic · 176d
Cleared Jun 21, 1990
DATASCOPE SLIDEWIRE(TM)
K901347 · DQX
Datascope Corp.
Cardiovascular · 90d
Cleared Jun 21, 1990
ESOPHAGEAL BALLOON DILATOR
K901424 · KNQ
Telemed Systems, Inc.
Gastroenterology & Urology · 87d
Cleared Jun 21, 1990
PYLORIC BALLOON DILATOR
K901425 · FAT
Telemed Systems, Inc.
Gastroenterology & Urology · 87d
Cleared Jun 21, 1990
COLONIC BALLOON DILATOR
K901426 · FFP
Telemed Systems, Inc.
Gastroenterology & Urology · 87d
Cleared Jun 21, 1990
BILIARY BALLOON DILATOR
K901432 · FGE
Telemed Systems, Inc.
Gastroenterology & Urology · 87d
Cleared Jun 21, 1990
SURE-FLEX ANASTOMOTIC BALLOON DILATOR
K901433 · FGE
Telemed Systems, Inc.
Gastroenterology & Urology · 87d
Cleared Jun 21, 1990
OSSEOTITE IRRIGATION UNIT
K901600 · EFS
Collagen Corp.
Dental · 76d
Cleared Jun 21, 1990
ACE WIRE TENSION CLAMP
K901984 · JEC
Buckman Co., Inc.
Orthopedic · 50d
Cleared Jun 21, 1990
PEDIA-TEMP(TM) LIQUID-CIRCULATING HYPO-HYPERTHERM.
K902268 · ILO
Seabrook Medical Systems, Inc.
Physical Medicine · 31d
Cleared Jun 21, 1990
ELECTRI-COOL(TM) LIQUID-CIRCULAT. THERMAL THERAPY
K902269 · ILO
Seabrook Medical Systems, Inc.
Physical Medicine · 31d
Cleared Jun 21, 1990
MODIFIED QM300 RHEUMATOID FACTOR TEST
K902462 · DHR
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 17d
Cleared Jun 21, 1990
BECKMAN KAPPA LIGHT CHAIN REAGENT (ADD'L CLAIMS)
K902484 · DFH
Beckman Instruments, Inc.
Immunology · 16d
Cleared Jun 21, 1990
BECKMAN LAMBDA LIGHT CHAIN REAGENT (ADD'L CLAIMS)
K902485 · DEH
Beckman Instruments, Inc.
Immunology · 16d
Cleared Jun 21, 1990
THE COMPANION NON-ELECTRIC LIFT CHAIR
K902600 · INN
Innovative Medical Engineering, Inc.
Physical Medicine · 9d
Cleared Jun 20, 1990
SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG
K900482 · GWF
Axon Systems, Inc.
Neurology · 139d
Cleared Jun 20, 1990
SPECTACLE FRAME
K900732 · HQZ
Seiko Corp.
Ophthalmic · 124d