FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
79777–79800 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 27, 2001
RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527
K010610 · ODC
Boston Scientific Corp
Gastroenterology & Urology · 26d
Cleared Mar 27, 2001
R & D DESIGNATION AP-047
K010611 · EJT
Jensen Industries, Inc.
Dental · 26d
Cleared Mar 26, 2001
PPCID- PNEUMATIC PERIPHERAL CIRCULATION IMPROVEMENT (FOOTREST) DEVICE
K000655 · IRP
Ahava Stein
Physical Medicine · 392d
Cleared Mar 26, 2001
FOGARTY VALVULOTOME, MODEL 700091
K001734 · MGZ
Edwards Lifesciences, LLC
Cardiovascular · 292d
Cleared Mar 26, 2001
DJ ORTHOPEDICS FEMORAL ANCHOR
K002829 · MBI
Dj Orthopedics, LLC
Orthopedic · 196d
Cleared Mar 26, 2001
AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION
K003345 · LPN
Ciba Vision Corporation
Ophthalmic · 152d
Cleared Mar 26, 2001
DORNIER MEDILAS D SKINPULSE LASER SYSTEM (SKINPULSE)
K003993 · GEX
Dornier Surgical Products, Inc.
General & Plastic Surgery · 90d
Cleared Mar 26, 2001
SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER
K004006 · GEX
Lumenis, Inc.
General & Plastic Surgery · 90d
Cleared Mar 26, 2001
LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100
K010013 · GEI
Valleylab, Inc.
General & Plastic Surgery · 83d
Cleared Mar 26, 2001
REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED)
K010088 · GWQ
Excel Tech. , Ltd.
Neurology · 74d
Cleared Mar 26, 2001
REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED)
K010089 · GWQ
Excel Tech. , Ltd.
Neurology · 74d
Cleared Mar 26, 2001
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED)
K010090 · GWF
Excel Tech. , Ltd.
Neurology · 74d
Cleared Mar 26, 2001
ULTRAVUE/P 2000T, ULTRAVUE/C 2000T (HIOXIFILCON B) SOFT (MULTIFOCAL TORIC)...
K010256 · LPL
Opti-Centre Laboratories
Ophthalmic · 56d
Cleared Mar 26, 2001
AMS FASCIAL-ANCHORING SYSTEM
K010277 · NEH
American Medical Systems, Inc.
General & Plastic Surgery · 55d
Cleared Mar 26, 2001
PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700,...
K010403 · NBW
Home Diagnostics, Inc.
Chemistry · 42d
Cleared Mar 23, 2001
COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS
K000977 · DTR
Olson Medical Sales, Inc.
Cardiovascular · 361d
Cleared Mar 23, 2001
BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING...
K003752 · JLW
Biosafe Laboratories, Inc.
Chemistry · 108d
Cleared Mar 23, 2001
JAS MAGNESIUM REAGENT
K003835 · JGJ
Jas Diagnostics, Inc.
Chemistry · 101d
Cleared Mar 23, 2001
CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411
K010389 · NFB
Chad Therapeutics, Inc.
Anesthesiology · 42d
Cleared Mar 23, 2001
SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL
K010598 · JPK
Quantimetrix Corp.
Hematology · 23d
Cleared Mar 23, 2001
FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES...
K010636 · MVN
Ciba Vision Corporation
Ophthalmic · 18d
Cleared Mar 23, 2001
FLEXI-SITE SP02 EAR SENSOR
K010718 · DPZ
Epic Medical Equipment Services, Inc.
Anesthesiology · 11d
Cleared Mar 22, 2001
MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300
K000724 · KDI
Medica S.R.L.
Gastroenterology & Urology · 381d
Cleared Mar 22, 2001
K.E.A.T.
K002154 · KPI
Emd Electronic Medical Devices, Corp.
Gastroenterology & Urology · 248d