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
105577–105600 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 28, 1994
MAG-1 SPECTACLE FRAME
K945342 · HQZ
Criss Optical Mfg. Co., Inc.
Ophthalmic · 27d
Cleared Nov 28, 1994
DERMAVBLADE(TM)
K945430 · MDM
Hasting'S Biomedical Corp.
General & Plastic Surgery · 97d
Cleared Nov 28, 1994
TROCAR ( ACCESORY)
K945457 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 21d
Cleared Nov 27, 1994
SURGICAL MICROSCOPE DRAPE
K944198 · MMP
Hydro-Med Products, Inc.
General Hospital · 90d
Cleared Nov 22, 1994
VIDENT IMPAC IMPLANT ACCESSORIES
K923395 · DZE
Vident
Dental · 865d
Cleared Nov 22, 1994
GLUMA 3 STEP BONDING SYSTEM/ GLUMA 3 PRIMER/DESENSITIZER
K933360 · KLE
Miles Inc., Dental Products
Dental · 501d
Cleared Nov 22, 1994
STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY
K933414 · KHQ
Baxter Diagnostics, Inc.
Chemistry · 497d
Cleared Nov 22, 1994
STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY
K934003 · DKA
Baxter Diagnostics, Inc.
Toxicology · 462d
Cleared Nov 22, 1994
TRIGEL MULTIFUNCTION ELECTRODE
K934505 · DRX
Physiometrix, Inc.
Cardiovascular · 433d
Cleared Nov 22, 1994
ADVANCED MAGMAG AC/BATTERY BREAST PUMP
K935249 · HGX
Pigeon Corp.
Obstetrics & Gynecology · 386d
Cleared Nov 22, 1994
DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA
K935307 · DDQ
Baxter Diagnostics, Inc.
Hematology · 385d
Cleared Nov 22, 1994
DANESHVAR'S DEVICE
K935494 · DXC
Y. Daneshvar
Cardiovascular · 372d
Cleared Nov 22, 1994
DADE INNOVIN II
K935702 · GJS
Baxter Diagnostics, Inc.
Hematology · 357d
Cleared Nov 22, 1994
ELECTRIC SURGICAL DRILL
K940016 · ERL
Alamo City Dental Supply Co.
Ear, Nose, Throat · 322d
Cleared Nov 22, 1994
MENISCAL SUTURE INSTRUMENTARIUM
K940287 · HRX
Richard Wolf Medical Instruments Corp.
Orthopedic · 305d
Cleared Nov 22, 1994
GYROSCAN T10-NT (RELEASE 4 SERIES SOFTWARE)
K940534 · LNH
Philips Medical Systems, Inc.
Radiology · 288d
Cleared Nov 22, 1994
INTERSPEC APOGEE RX400 ULTRASOUND IMAGING SYSTEM AND DOPPLER ULTRASOUND...
K940671 · ITX
Interspec, Inc.
Radiology · 279d
Cleared Nov 22, 1994
PIONEER LABORATORIES BONE SCREW
K940690 · HWC
Pioneer Surgical Technology
Orthopedic · 279d
Cleared Nov 22, 1994
EPIVIEW
K940895 · MGP
Convatec, A Bristol-Myers Squibb Co.
General & Plastic Surgery · 271d
Cleared Nov 22, 1994
UNBREAKABLE LENS
K941437 · HQY
Nam Hing Plastic Factory , Ltd.
Ophthalmic · 243d
Cleared Nov 22, 1994
AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT
K941550 · HNO
Chiron Vision Corp.
Ophthalmic · 237d
Cleared Nov 22, 1994
GIP/MED-GLOBE STONE EXTRACTOR BASKETS
K942005 · LQR
Medi-Globe Corp.
Gastroenterology & Urology · 211d
Cleared Nov 22, 1994
KEELER MULTILASE 3000
K942180 · HQF
Keeler Instruments, Inc.
Ophthalmic · 202d
Cleared Nov 22, 1994
VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS
K942211 · BTY
Sensor Medics Corp.
Anesthesiology · 201d