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
59329–59352 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 21, 2007
INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST
K070660 · KHE
Alfa Scientific Designs, Inc.
Hematology · 104d
Cleared Jun 21, 2007
ENDOSSEOUS DENTAL IMPLANT SYSTEM
K070841 · DZE
Southern Implants, Inc.
Dental · 86d
Cleared Jun 21, 2007
FLEXGUARD
K070924 · GEX
Allmed Systems, Inc.
General & Plastic Surgery · 79d
Cleared Jun 21, 2007
CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0
K070941 · NBW
Taidoc Technology Corporation
Chemistry · 78d
Cleared Jun 21, 2007
SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES
K070975 · ELC
Hu-Friedy Mfg. Co., Inc.
Dental · 76d
Cleared Jun 21, 2007
IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN...
K071002 · NQD
Beckman Coulter, Inc.
Chemistry · 73d
Cleared Jun 21, 2007
SYNERAD OMNI, MODELS AN6255 AND AN6265
K071430 · KPR
Analogic Corp.
Radiology · 29d
Cleared Jun 20, 2007
MESOSFOL SURGICAL FILM
K062558 · FTM
Biomet Manufacturing Corp
General & Plastic Surgery · 294d
Cleared Jun 20, 2007
CONTIPLEX STIM CONTINUOUS NERVE BLOCK SET
K063282 · CAZ
B.Braun Medical, Inc.
Anesthesiology · 232d
Cleared Jun 20, 2007
GFX NERVE ABLATION SYSTEM
K063753 · GXD
Aci, Inc.
Neurology · 183d
Cleared Jun 20, 2007
QUANTA PLEX CELIAC IGA PROFILE
K063818 · MVM
Inova Diagnostics, Inc.
Immunology · 180d
Cleared Jun 20, 2007
CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR)
K070490 · BWF
Advanced Circulatory Systems, Inc.
Anesthesiology · 120d
Cleared Jun 20, 2007
GENESISCS COMPONENT CONCENTRATING SYSTEM
K070666 · JQC
Perfusion Partners & Assoc., Inc.
Hematology · 100d
Cleared Jun 20, 2007
THD
K070815 · JAF
G.F. S.R.L.
Radiology · 86d
Cleared Jun 20, 2007
FEEL-JECT INSULIN SYRINGE
K070917 · FMF
Feel Tech
General Hospital · 79d
Cleared Jun 20, 2007
CLEARFIL MAJESTY POSTERIOR PLT
K071169 · EBF
Kuraray Medical, Inc.
Dental · 54d
Cleared Jun 20, 2007
SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001
K071180 · FTD
Engineered Medical Solutions Co., LLC
General & Plastic Surgery · 51d
Cleared Jun 20, 2007
KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5
K071195 · IYX
Ani-Kal Ii, LLC
Radiology · 51d
Cleared Jun 20, 2007
IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONS
K071232 · LLZ
Tomtec Imaging Systems GmbH
Radiology · 48d
Cleared Jun 20, 2007
XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM
K071233 · MWP
Kub Technologies, Inc.
Radiology · 48d
Cleared Jun 20, 2007
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS...
K071399 · LHN
Sicel Technologies, Inc.
Radiology · 30d
Cleared Jun 20, 2007
UNITE BIOMATRIX
K071425 · KGN
Pegasus Biologics, Inc.
General & Plastic Surgery · 28d
Cleared Jun 19, 2007
ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM,...
K063232 · CEW
Biokit, S.A.
Chemistry · 237d
Cleared Jun 18, 2007
BIS EEG MONITOR VIEW
K062613 · OLW
Aspect Medical Systems, Inc.
Neurology · 286d