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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
125137–125160 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 24, 1990
TENSTAPLE ORTHOPEDIC STAPLING SYSTEM
K896471 · JDR
Tenstaple, Inc.
Orthopedic · 253d
Cleared Jul 24, 1990
ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
K900263 · FOZ
Arrow Intl., Inc.
General Hospital · 187d
Cleared Jul 24, 1990
R-BAND(TM) RESPIRATORY SENSOR
K900264 · BZQ
Buckman Co., Inc.
Anesthesiology · 187d
Cleared Jul 24, 1990
BIODEX LIFT SIMULATOR
K900450 · IKK
Biodex Corp.
Physical Medicine · 175d
Cleared Jul 24, 1990
BEHRING CHROMOTIMER
K901829 · JJQ
Behring Diagnostics, Inc.
Hematology · 91d
Cleared Jul 24, 1990
L.D.X LIPID MONITORING SYSTEM
K901900 · CHH
Cholestech Corp.
Chemistry · 88d
Cleared Jul 24, 1990
AUTOWAND(TM) 7XXX SERIES
K902059 · CAC
Boehringer Laboratories
Anesthesiology · 78d
Cleared Jul 24, 1990
FESAN SUNGLASSES
K902117 · HQY
Fesan, S.A.
Ophthalmic · 76d
Cleared Jul 24, 1990
SUNGLASSES
K902186 · HQY
Creative Paper Products, Inc.
Ophthalmic · 71d
Cleared Jul 24, 1990
ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB)
K902455 · LCP
Analytical Control Systems, Inc.
Hematology · 50d
Cleared Jul 24, 1990
ABNORMAL GLYCOHEMOGLOBIN CONTROL
K902457 · LCP
Analytical Control Systems, Inc.
Hematology · 50d
Cleared Jul 24, 1990
WEEVAC 1 PORTABLE RESCUE STRETCHER
K902474 · FPP
W. Murphy Ent., Inc.
General Hospital · 49d
Cleared Jul 24, 1990
LANDERS VITRECTOMY LENS RING W/INFUSION
K902496 · HNH
Ocular Instruments, Inc.
Ophthalmic · 49d
Cleared Jul 24, 1990
SAXON RIBBED CONDOMS
K902509 · HIS
Safetex Corp.
Obstetrics & Gynecology · 49d
Cleared Jul 24, 1990
MITEK ANCHOR II
K902751 · JDR
Mitek Surgical Products, Inc.
Orthopedic · 32d
Cleared Jul 24, 1990
TOXOPLASMA GONDII IGG
K902792 · LGD
Pharmacia Diagnostics, Inc.
Microbiology · 28d
Cleared Jul 24, 1990
THERMOSCAN-INSTANT THERMOMETER MODEL IR-4000
K902912 · FLL
Thermoscan, Inc.
General Hospital · 21d
Cleared Jul 23, 1990
KRONNER SPHERICAL CUTTERS
K894228 · HWT
Kronner Medical
Orthopedic · 399d
Cleared Jul 23, 1990
PHARMATRONICS NEBULIZER
K896536 · CAF
Diversatronics, Inc.
Anesthesiology · 250d
Cleared Jul 23, 1990
SPIRO ANALYZER MODEL ST 250
K901308 · BZG
Futuremed Div. of Future Impex Corp.
Anesthesiology · 125d
Cleared Jul 23, 1990
INSTRUMENTS FOR NEUROLOGICAL SURGERY
K901313 · HAE
Von Zeppelin GmbH
Neurology · 125d
Cleared Jul 23, 1990
ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED
K901406 · JWH
Depuy, Inc.
Orthopedic · 119d
Cleared Jul 23, 1990
WALLACE INTRAUTERINE INSEMINATION CATHETER
K901530 · EJT
Gynescope Corp.
Dental · 112d
Cleared Jul 23, 1990
TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX
K901845 · KGX
3M Company
General & Plastic Surgery · 90d