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

Filters: Cleared only ×
176,076 results
68305–68328 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 24, 2004
MARE DENTAL OPERATIVE UNIT
K041458 · EIA
Denimed Electronica S.H.
Dental · 84d
Cleared Aug 24, 2004
PENCIL POINT NEEDLE
K041843 · BSP
Epimed International, Inc.
Anesthesiology · 47d
Cleared Aug 24, 2004
NEXUS PAV LUER LOCK DEVICE, MODEL NIS-4
K041845 · FPA
Nexus Medical, LLC
General Hospital · 47d
Cleared Aug 24, 2004
MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER
K041974 · BTI
Med2000 S.R.L.
Anesthesiology · 33d
Cleared Aug 24, 2004
PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION...
K042081 · FRN
Hospira, Inc.
General Hospital · 21d
Cleared Aug 24, 2004
FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-311
K042138 · DXN
Sein Electronics Co., Ltd.
Cardiovascular · 15d
Cleared Aug 23, 2004
SPOT CHECK PULSE OXIMETER,512/513
K032949 · DQA
Respironics Novametrix, Inc.
Anesthesiology · 336d
Cleared Aug 23, 2004
VECTORVISION HIP 3.0
K040368 · HAW
Brainlab AG
Neurology · 192d
Cleared Aug 23, 2004
BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN
K041371 · EJR
Novamin Technology, Inc.
Dental · 91d
Cleared Aug 23, 2004
SMITH & NEPHEW GRAFT DELIVERY SYSTEM
K041976 · FMF
Smith & Nephew, Inc.
General Hospital · 32d
Cleared Aug 23, 2004
AIRGUARD VALVED INTRODUCER
K042036 · DYB
C.R. Bard, Inc.
Cardiovascular · 25d
Cleared Aug 23, 2004
MODIFICATION TO PROTEGE GPS SELF-EXPANDING NITINOL STENT
K042204 · FGE
Ev3, Inc.
Gastroenterology & Urology · 7d
Cleared Aug 20, 2004
OSSATURA DENTAL
K031813 · LYC
Isotis NV
Dental · 435d
Cleared Aug 20, 2004
RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION...
K040996 · NIX
Gyrus Ent LLC
Ear, Nose, Throat · 126d
Cleared Aug 20, 2004
IMMUNOCARD TOXINS A & B, MODEL 712050
K041003 · LLH
Meridian Bioscience, Inc.
Microbiology · 123d
Cleared Aug 20, 2004
POWDER-FREE NITRILE EXAMINATION GLOVES
K041276 · LZA
Shanghai Motex Healthcare Co., Ltd.
General Hospital · 100d
Cleared Aug 20, 2004
BODY CLOCK STIMPLUS AND STIMPLUS PRO
K041359 · GZJ
Body Clock Health Care, Ltd.
Neurology · 91d
Cleared Aug 20, 2004
MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO....
K041409 · GZL
Inomed GmbH
Neurology · 85d
Cleared Aug 20, 2004
SYNTHETIC SURGICAL GLOVE-POWDERFREE NUZONE X2
K041436 · KGO
Terang Nusa Sdn Bhd
General Hospital · 84d
Cleared Aug 20, 2004
MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM
K041840 · KPS
Medx, Inc.
Radiology · 43d
Cleared Aug 20, 2004
POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR
K041848 · LZA
Pt. Smartglove Indonesia
General Hospital · 43d
Cleared Aug 20, 2004
NOBELDIRECT OD IMPLANT
K041876 · DZE
Nobel Biocare Uas, Inc.
Dental · 39d
Cleared Aug 20, 2004
POWDER-FREE BLUE VINYL EXAM GLOVES
K041945 · LYZ
Glormed Intl., Inc.
General Hospital · 32d
Cleared Aug 20, 2004
GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000
K041981 · GEI
Guidant Corporation
General & Plastic Surgery · 28d