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
91729–91752 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 21, 1997
ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)
K973369 · LBR
Roche Diagnostic Systems, Inc.
Chemistry · 74d
Cleared Nov 21, 1997
SYNTAC SPRINT
K973397 · EMA
Ivoclar North America, Inc.
Dental · 73d
Cleared Nov 21, 1997
ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100
K973642 · EHD
Instrumentarium Imaging, Inc.
Radiology · 58d
Cleared Nov 21, 1997
REFLECTIONS
K973776 · DYW
Cdb Corp.
Dental · 49d
Cleared Nov 21, 1997
HIGH RISK POWDERFREE LATEX EXAMINATION GLOVES (BLUE COLOUR)
K973801 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 46d
Cleared Nov 21, 1997
HIGH RISK POWDERED LATEX EXAMINATION GLOVES (BLUE COLOUR)
K973815 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 45d
Cleared Nov 21, 1997
GIOTTO HT
K973856 · IZH
Sitco, Inc.
Radiology · 43d
Cleared Nov 21, 1997
VARIAN MULTILEAF COLLIMATOR WITH DYNAMIC ARC THERAPY FEATURE
K973889 · IYE
Varian Medical Systems, Inc.
Radiology · 38d
Cleared Nov 21, 1997
STEALTHSTATION SYSTEM
K974161 · HAW
Surgical Navigation Technologies, Inc.
Neurology · 86d
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