Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
73777–73800 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 2003
COOPERSURGICAL OOCYTE RECOVERY NEEDLES
K023930 · MQE
CooperSurgical, Inc.
Obstetrics & Gynecology · 58d
Cleared Jan 22, 2003
ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV...
K024177 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 35d
Cleared Jan 22, 2003
MODIFICATION TO EBI XFIX DFS SYSTEM METAPHYSEAL CORRECTION SYSTEM
K024248 · KTT
Ebi, L.P.
Orthopedic · 30d
Cleared Jan 22, 2003
ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY
K030064 · ITX
Sonosite,Inc.
Radiology · 15d
Cleared Jan 21, 2003
EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830
K010714 · FGE
Medi-Globe Corp.
Gastroenterology & Urology · 683d
Cleared Jan 21, 2003
BOUSSIGNAC C.P.A.P. DEVICE
K013884 · BYE
Vygon SA
Anesthesiology · 424d
Cleared Jan 21, 2003
COMPUMEDICS SOMTE SYSTEM
K021176 · MNR
Compumedics Limited
Anesthesiology · 284d
Cleared Jan 21, 2003
INNER-LOCK LOCKING INTRODUCER SHEATHS
K022170 · DYB
Rex Medical
Cardiovascular · 202d
Cleared Jan 21, 2003
FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI...
K023009 · DFH
The Binding Site, Ltd.
Immunology · 134d
Cleared Jan 21, 2003
FREELITE HUMAN LAMBDA FREE KIT
K023131 · DEH
The Binding Site, Ltd.
Immunology · 134d
Cleared Jan 21, 2003
UCC DENTAL MATERIAL
K023790 · EJT
Precious Chemicals U.S.A., Inc.
Dental · 69d
Cleared Jan 21, 2003
PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000...
K023795 · JXN
Lin-Zhi International, Inc.
Toxicology · 69d
Cleared Jan 21, 2003
LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER...
K030074 · JIX
Cliniqa Corporation
Immunology · 13d
Cleared Jan 17, 2003
OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB
K022035 · JEY
Osteomedics, Inc.
Dental · 210d
Cleared Jan 17, 2003
HYDROFERA BACTERIOSTATIC WOUND DRESSING
K023138 · FRO
Hydrofera, LLC
General & Plastic Surgery · 119d
Cleared Jan 17, 2003
NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE
K023528 · JWH
Centerplus Orthopedics, Inc.
Orthopedic · 88d
Cleared Jan 17, 2003
LESSER METATARSAL PHALANGEAL JOINT IMPLANT
K023531 · KWH
Nexa Orthopedics, Inc.
Orthopedic · 88d
Cleared Jan 17, 2003
BARCO MEDIS 5MP2 AURA
K023533 · LLZ
Barco N.V.
Radiology · 88d
Cleared Jan 17, 2003
TRIPTER X-1 COMPACT DUET
K023535 · LNS
Direx Systems Corp.
Gastroenterology & Urology · 88d
Cleared Jan 17, 2003
MAXIM ACCEL KNEE SYSTEM
K023546 · JWH
Biomet, Inc.
Orthopedic · 87d
Cleared Jan 17, 2003
STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM
K023580 · DZE
Sterngold
Dental · 85d
Cleared Jan 17, 2003
SILVERLON ADHESIVE STRIP
K023609 · FRO
Argentum International, LLC
General & Plastic Surgery · 81d
Cleared Jan 17, 2003
VITIQUE SYSTEM
K023649 · EMA
Dmg USA, Inc.
Dental · 79d
Cleared Jan 17, 2003
MAXONE IV FLUID/BLOOD WARMER, MODEL 102
K023653 · LGZ
Automatic Medical Technologies, Inc.
General Hospital · 79d