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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
47737–47760 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 12, 2011
WALDO PATIENT MONITOR
K110334 · DRG
Waldo Health
Cardiovascular · 67d
Cleared Apr 12, 2011
SYNGO.CT CARDIAC FUNCTION
K110366 · JAK
Siemens AG
Radiology · 64d
Cleared Apr 11, 2011
TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE
K101072 · LPH
Howmedica Osteonics Corp.
Orthopedic · 357d
Cleared Apr 11, 2011
AMC-20 PORTABLE DENTAL CART MODEL AMC-20
K101332 · EIA
Aseptico, Inc.
Dental · 334d
Cleared Apr 11, 2011
TAPER OXINIUM FEMORAL HEAD
K110101 · LZO
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Apr 11, 2011
LATARJET CORTICAL SCREW SET
K110763 · HWC
T.A.G. Medical Products Corporation,...
Orthopedic · 24d
Cleared Apr 08, 2011
CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET
K092269 · LDJ
Randox Laboratories, Ltd.
Toxicology · 619d
Cleared Apr 08, 2011
SMITH & NEWPHEW ULTRABRAID II SUTURE
K101377 · GAT
Smith & Newphew, Inc.
General & Plastic Surgery · 326d
Cleared Apr 08, 2011
INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA...
K101581 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 305d
Cleared Apr 08, 2011
THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY
K101742 · DIO
Microgenics Corp.
Toxicology · 290d
Cleared Apr 08, 2011
THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY
K101744 · LDJ
Microgenics Corp.
Chemistry · 290d
Cleared Apr 08, 2011
THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY
K101745 · DKZ
Microgenics Corp.
Chemistry · 290d
Cleared Apr 08, 2011
THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY
K101746 · LCM
Microgenics Corp.
Chemistry · 290d
Cleared Apr 08, 2011
THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS
K101752 · DKB
Microgenics Corp.
Chemistry · 290d
Cleared Apr 08, 2011
THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY
K101753 · LAF
Microgenics Corp.
Chemistry · 290d
Cleared Apr 08, 2011
THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY
K101754 · DJG
Microgenics Corp.
Toxicology · 290d
Cleared Apr 08, 2011
HYDROFIX VASO SHIELD
K101805 · OMR
Mimedx Group, Inc.
Cardiovascular · 284d
Cleared Apr 08, 2011
SCENARIA WHOLE-BODY X-RAY CT SYSTEM
K101888 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 275d
Cleared Apr 08, 2011
D-STAT DRY SILVER
K102212 · QSX
Vascular Solutions, Inc.
General & Plastic Surgery · 245d
Cleared Apr 08, 2011
ULTIMATE VIT ENHAMCER (UVE)
K102222 · HQE
Medical Instrument Development...
Ophthalmic · 245d
Cleared Apr 08, 2011
AGILIS ES STEERABLE INTRODUCER
K103083 · DYB
St Jude Medical
Cardiovascular · 171d
Cleared Apr 08, 2011
NICOLET WIRELESS EEG
K103140 · GWL
Carefusion 209, Inc.
Neurology · 165d
Cleared Apr 08, 2011
ACAM 5 AUDIOMETER SYSTEM
K103298 · EWO
Acousticon GmbH
Ear, Nose, Throat · 151d
Cleared Apr 08, 2011
DENOVO TEDDY GEL INFANT HEEL WARMER
K103549 · MPO
Denovo Products, LLC
Physical Medicine · 126d