FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

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

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175,820 results
133825–133848 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 18, 1988
MICROAIR FLUIDIZED AIR BED
K884529 · INX
Gsi Development Co.
Physical Medicine · 21d
Cleared Nov 18, 1988
TRIAD-EP II, PUSHBUTTON, CABLE INPUT
K884532 · DRO
Cardiotronics, Inc.
Cardiovascular · 21d
Cleared Nov 17, 1988
CSI/QCT
K880404 · KGI
Columbia Scientific, Inc.
Radiology · 293d
Cleared Nov 17, 1988
MODEL 2331T PATIENT PROGRAMMER
K880738 · KRG
Medtronic Vascular
Cardiovascular · 267d
Cleared Nov 17, 1988
DYNAMIC CRUCIATE TESTER
K881876 · LYH
Dyonics, Inc.
Neurology · 197d
Cleared Nov 17, 1988
MARQUETTE 1200 DEFIBRILLATOR
K882067 · MKJ
Marquette Electronics, Inc.
Cardiovascular · 184d
Cleared Nov 17, 1988
LOGIC 3 ELECTROCARDIOGRAPH
K882472 · DPS
Cel-Med Co., Inc.
Cardiovascular · 155d
Cleared Nov 17, 1988
IMZ O-RING ATTACHMENT
K883211 · DZE
Interpore Intl.
Dental · 111d
Cleared Nov 17, 1988
DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602
K883478 · EWO
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 93d
Cleared Nov 17, 1988
TDK ECG ELECTRODE, MEL-10L
K883643 · DRX
Tdk Corp.
Cardiovascular · 86d
Cleared Nov 17, 1988
MODIFIED SPECTRAX SX/SXT & PASYS/PASYS ST MODELS
K883755 · DXY
Medtronic Vascular
Cardiovascular · 76d
Cleared Nov 17, 1988
MASKS, VARIOUS TYPES OF SURGICAL MASKS
K883827 · FXX
Greene International Corp.
General Hospital · 69d
Cleared Nov 17, 1988
ETA
K883853 · LRA
Sevrain-Tech, Inc.
Ear, Nose, Throat · 65d
Cleared Nov 17, 1988
BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER
K884033 · DSB
Biodynamics Corp.
Cardiovascular · 55d
Cleared Nov 17, 1988
MINIX 8340, 8341, 8342 MINIX-ST 8330, 8331
K884215 · DXY
Medtronic Vascular
Cardiovascular · 42d
Cleared Nov 17, 1988
CUSHION FLEX(TM)
K884387 · BSJ
Life Design Systems, Inc.
Anesthesiology · 30d
Cleared Nov 17, 1988
BLADEMATE
K884448 · MMK
V.I.R. Engineering, Inc.
General Hospital · 27d
Cleared Nov 17, 1988
MODULAR COLLARED HJD TOTAL HIP SYSTEM
K884457 · JDI
Richards Medical Co., Inc.
Orthopedic · 24d
Cleared Nov 17, 1988
BEAVER(R) HANDLE
K884512 · GDZ
Bd Becton Dickinson Vacutainer...
General & Plastic Surgery · 21d
Cleared Nov 17, 1988
FORCEPS, TOWEL, BACKHAUS-TSK (BRAND) TOWEL
K884514 · GEN
Gatewood and Associates, Ltd.
General & Plastic Surgery · 21d
Cleared Nov 17, 1988
TRIAD-EP II, PLATE INPUT
K884530 · DRO
Cardiotronics, Inc.
Cardiovascular · 20d
Cleared Nov 17, 1988
IOP ADJUSTABLE STIRRUP
K884558 · BWN
Mend Technologies, Inc.
General & Plastic Surgery · 17d
Cleared Nov 16, 1988
ORTHOTONE
K872111 · HLL
Orthotone Corp.
Ophthalmic · 534d
Cleared Nov 16, 1988
SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION
K875378 · KPS
Shimadzu Precision Instruments, Inc.
Radiology · 321d