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
87121–87144 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 1998
MODULAP
K983623 · GCJ
Atc Technologies, Inc.
General & Plastic Surgery · 64d
Cleared Dec 18, 1998
C.T.M. MOBILITY SCOOTER, MODEL # HS-686
K983662 · INI
Warepalmy Enterprise, LLC (Usa)
Physical Medicine · 60d
Cleared Dec 18, 1998
C.T.M. MOBILITY SCOOTER, MODEL # HS-666
K983663 · INI
Warepalmy Enterprise, LLC (Usa)
Physical Medicine · 60d
Cleared Dec 18, 1998
SULZER ORTHOPEDICS APOLLO REVISION/CONSTRAINED KNEE TIBIAL BASEPLATE STEM PLUGS
K983733 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 57d
Cleared Dec 18, 1998
EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020
K983741 · GXY
Axelgaard Mfg. Co., Ltd.
Neurology · 57d
Cleared Dec 18, 1998
YASARGIL TITANIUM ANEURYSM CLIPS
K983758 · HCH
Aesculap, Inc.
Neurology · 53d
Cleared Dec 18, 1998
SYNTHES SYNMESH
K983766 · EZX
Synthes (Usa)
General & Plastic Surgery · 53d
Cleared Dec 18, 1998
MODIFICATION TO VENTURE IHO 100 COMPLETE HOME OXYGEN SYSTEM
K983777 · CAW
Invacare Corp.
Anesthesiology · 53d
Cleared Dec 18, 1998
MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
K983780 · LPN
Alcon Laboratories
Ophthalmic · 52d
Cleared Dec 18, 1998
TRANSFERRIN SPQ III ANTIBODY REAGENT SET
K983880 · DDG
DiaSorin, Inc.
Immunology · 46d
Cleared Dec 18, 1998
DEPUY ORTHOTECH SPIKED WASHER
K983906 · HTN
DePuy Orthopaedics, Inc.
Orthopedic · 45d
Cleared Dec 18, 1998
HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO
K983924 · DHN
Immuno Concepts, Inc.
Immunology · 44d
Cleared Dec 18, 1998
OPTI-ONE MULTI-PURPOSE SOLUTION
K983973 · LPN
Alcon Laboratories
Ophthalmic · 39d
Cleared Dec 18, 1998
LASERSCOPE COOLSPOT
K984110 · GEX
Laserscope
General & Plastic Surgery · 31d
Cleared Dec 18, 1998
MODIFICATION TO SKVEKPATCH
K984177 · KMF
Marine Polymer Technologies, Inc.
General & Plastic Surgery · 28d
Cleared Dec 18, 1998
NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL...
K984245 · HAW
Radionics, Inc.
Neurology · 21d
Cleared Dec 18, 1998
OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS
K984302 · MNH
Osteonics Corp.
Orthopedic · 16d
Cleared Dec 18, 1998
ULTRACARE NEUTRALIZING TABLETS
K984383 · LPN
Allergan, Inc.
Ophthalmic · 10d
Cleared Dec 18, 1998
LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213
K984396 · LRM
Bio-Rad
Immunology · 9d
Cleared Dec 18, 1998
LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 203
K984397 · DHN
Bio-Rad
Immunology · 9d
Cleared Dec 18, 1998
LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201
K984398 · DHN
Bio-Rad
Immunology · 9d
Cleared Dec 18, 1998
LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204
K984399 · DHN
Bio-Rad
Immunology · 9d
Cleared Dec 18, 1998
LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202
K984400 · DHN
Bio-Rad
Immunology · 9d
Cleared Dec 17, 1998
SPIFE ALKALINE HEMOGLOBIN
K982426 · JBD
Helena Laboratories
Hematology · 157d