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
91225–91248 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 1997
KNIGHT LIGHT NONLUBRICATED CONDOM
K960552 · HIS
Global Protection Corp.
Obstetrics & Gynecology · 651d
Cleared Nov 20, 1997
MARKMAN TEMPLATE SYSTEM
K970306 · GAH
Barry Markman, M.D.
General & Plastic Surgery · 297d
Cleared Nov 20, 1997
CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM)
K971329 · GWQ
Ctf Systems, Inc.
Neurology · 224d
Cleared Nov 20, 1997
EPOCH 2000 NEUROLOGICAL WORKSTATION
K971819 · GWF
Axon Systems, Inc.
Neurology · 188d
Cleared Nov 20, 1997
ORTHOPEDIC SCREW SYSTEM
K972217 · HWC
Ferguson Medical
Orthopedic · 161d
Cleared Nov 20, 1997
ORTHOPEDIC PLATE SYSTEM
K972219 · HRS
Ferguson Medical
Orthopedic · 161d
Cleared Nov 20, 1997
HEMOCHRON CITRATE APTT
K972831 · GFO
International Technidyne Corp.
Hematology · 113d
Cleared Nov 20, 1997
FLUID CENTURION (4-100-00)
K973025 · FLN
Northgate Technologies, Inc.
General Hospital · 98d
Cleared Nov 20, 1997
MACOM
K973148 · LLZ
A.Stein - Regulatory Affairs Consulting
Radiology · 90d
Cleared Nov 20, 1997
DUAL RADIATION TARGETING SYSTEM DRTS DRAPE
K973162 · IWE
Hogan & Hartson
General Hospital · 90d
Cleared Nov 20, 1997
HOWMEDICA TOTAL STABILIZER KNEE COMPONENTS
K973164 · JWH
Howmedica Corp.
Orthopedic · 87d
Cleared Nov 20, 1997
FLEXLENS, FLEXLENS TORIC
K973192 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 87d
Cleared Nov 20, 1997
THE CORIFIX DYNAMIC HIP SCREW SYSTEM
K973231 · KTT
Corin USA
Orthopedic · 85d
Cleared Nov 20, 1997
SYNTHES PROXIMAL FEMORAL NAIL(PFN) SYSTEM MODIFICATION
K973240 · HTY
Synthes (Usa)
Orthopedic · 84d
Cleared Nov 20, 1997
KLS-MARTIN INTRAORAL DISTRACTOR
K973275 · MQN
KLS-Martin L.P.
Dental · 79d
Cleared Nov 20, 1997
AUTODELFIA NEONATAL HTSH L KIT (B077-112)
K973276 · JLW
Eg &G Wallac
Chemistry · 79d
Cleared Nov 20, 1997
S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD
K973307 · LZO
Johnson & Johnson Professionals, Inc.
Orthopedic · 78d
Cleared Nov 20, 1997
HOFFMANN II COMPACT PERIARTICULAR CLAMP
K973321 · KTT
Howmedica, Inc.
Orthopedic · 77d
Cleared Nov 20, 1997
TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES
K973442 · IKT
Medelec, Inc. D.B.A. Teca Corp.
Neurology · 70d
Cleared Nov 20, 1997
TECA MYOJECT DISPOSABLE NEEDLE ELECTRODES
K973444 · IKT
Medelec, Inc. D.B.A. Teca Corp.
Neurology · 70d
Cleared Nov 20, 1997
CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND...
K973475 · DTR
Medtronic Vascular
Cardiovascular · 69d
Cleared Nov 20, 1997
VARIABLE PARALLEL PIN
K973521 · DZE
Sulzer Calcitek, Inc.
Dental · 64d
Cleared Nov 20, 1997
NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES
K973529 · IKT
Medicotest A/S
Neurology · 63d
Cleared Nov 20, 1997
AL-47 (ISOFILCON) SOFT (SPHERICAL) DAILY WEAR CONTACT LENS
K973597 · LPL
Martin Dalsing
Ophthalmic · 59d