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
82081–82104 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 13, 2000
POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING...
K002701 · LYY
Alliance Rubber Products Sdn. Bhd.
General Hospital · 14d
Cleared Sep 13, 2000
PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS
K992476 · MWS
Pilling Weck Surgical
Cardiovascular · 415d
Cleared Sep 13, 2000
HUMID-HEAT
K993773 · BTT
Hudson Rcj AB
Anesthesiology · 310d
Cleared Sep 13, 2000
ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER...
K994137 · LYC
Atrix Laboratories, Inc.
Dental · 281d
Cleared Sep 12, 2000
INSIGHT IMAGE GUIDED SURGICAL SYSTEM
K001642 · HAW
Surgical Insights, Inc.
Neurology · 105d
Cleared Sep 12, 2000
ACCUWARM EMG HEAT LAMP
K001800 · IKN
Rjl Associates, LLC
Neurology · 90d
Cleared Sep 12, 2000
REFRACTIVE SURGERY BLADES
K001806 · HNO
Millennium Biomedical, Inc.
Ophthalmic · 89d
Cleared Sep 12, 2000
MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT
K002044 · HLJ
Magna Fortis Corporation
Ophthalmic · 69d
Cleared Sep 12, 2000
USS VAS
K002517 · KWP
Synthes (Usa)
Orthopedic · 28d
Cleared Sep 12, 2000
EL-ANA PROFILES-2K1
K002559 · LJM
Theratest Laboratories, Inc.
Immunology · 26d
Cleared Sep 12, 2000
MOSS MIAMI 6.35MM ROD SYSTEM MONOAXIAL SCREWS, POLYAXIAL REDUCTION SCREWS AND...
K002607 · KWP
Depuyacromed
Orthopedic · 21d
Cleared Sep 12, 2000
MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022
K991502 · JXG
Medtronic PS Medical
Neurology · 502d
Cleared Sep 11, 2000
TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET
K001461 · KPE
Biometrix , Ltd.
General Hospital · 124d
Cleared Sep 11, 2000
VIRIDIS LASER
K001784 · GEX
Cosmos Medical Technology
General & Plastic Surgery · 90d
Cleared Sep 11, 2000
ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST
K001900 · LRM
Helix Diagnostics, Inc.
Immunology · 81d
Cleared Sep 11, 2000
C02 LASER MULTIPULSE
K002032 · GEX
Asclepion-Meditec AG
General & Plastic Surgery · 70d
Cleared Sep 11, 2000
FMS SOLO
K002040 · HRX
Future Medical Systems, Inc.
Orthopedic · 68d
Cleared Sep 11, 2000
PROLITE VL PULSED LIGHT SYSTEM
K002072 · GEX
Medical Bio Care Sweden AB
General & Plastic Surgery · 66d
Cleared Sep 11, 2000
GOLDEN-RULE SCALING CATHETER
K002416 · DQO
Medical Device Technologies, Inc.
Cardiovascular · 34d
Cleared Sep 11, 2000
LATEX EXAMINATION GLOVES, POWDERED, (CONTAINS 100 MICROGRAMS OR LESS OF TOTAL...
K002448 · LYY
Oon Corp. Resources
General Hospital · 33d
Cleared Sep 11, 2000
FETALTROL
K002511 · JPK
Trillium Diagnostics, LLC
Hematology · 27d
Cleared Sep 11, 2000
DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505
K002722 · DXN
Jawon Medical Co., Ltd.
Cardiovascular · 11d
Cleared Sep 11, 2000
INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K
K002739 · MEA
Baxter Healthcare Corp
General Hospital · 10d
Cleared Sep 08, 2000
VITALOGRAPH BASE STATION
K000599 · BZG
Vitalograph, Inc.
Anesthesiology · 199d