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
76969–76992 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 07, 2002
OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND...
K012891 · DQA
Nellcor Puritan Bennett, Inc.
Anesthesiology · 191d
Cleared Mar 07, 2002
IMUBIND PLASMA PAI-1 ELISA,MODEL 822
K013168 · GGP
American Diagnostica, Inc.
Hematology · 167d
Cleared Mar 07, 2002
COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS
K014035 · GEX
Cooltouch Corp.
General & Plastic Surgery · 90d
Cleared Mar 07, 2002
TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE...
K014041 · HCG
Cordis Neurovascular
Neurology · 90d
Cleared Mar 07, 2002
BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145
K014075 · DQX
Baylis Medical Co., Inc.
Cardiovascular · 86d
Cleared Mar 07, 2002
NON-EUGENOL TEMPORARY CEMENT
K020158 · EMB
J. Morita USA, Inc.
Dental · 49d
Cleared Mar 07, 2002
MEDELA SYMPHONY BREAST PUMP, MODEL 024
K020518 · HGX
Medela, Inc.
Obstetrics & Gynecology · 16d
Cleared Mar 07, 2002
VIATRONIX V3D COLON
K020658 · LLZ
Viatronix, Inc.
Radiology · 6d
Cleared Mar 06, 2002
PRIME ECG SYSTEM
K012414 · DPS
Meridian Medical Technologies, Inc.
Cardiovascular · 219d
Cleared Mar 06, 2002
TOWEL DRAPE, MODELS 4409, 4410
K012957 · KKX
Dynarex Corp.
General Hospital · 183d
Cleared Mar 06, 2002
XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X
K013473 · MCW
Xtrak Medical, Inc.
Cardiovascular · 139d
Cleared Mar 06, 2002
REBILDA SC
K014111 · EBF
Voco GmbH
Dental · 82d
Cleared Mar 06, 2002
DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T
K020156 · MID
Axis-Shield Diagnostics, Ltd.
Immunology · 48d
Cleared Mar 06, 2002
ULTRA TOUCH POWDERED LATEX EXAMINATION GLOVES
K020359 · LYY
Ar Alliance Healthcare Sdn. Bhd.
General Hospital · 30d
Cleared Mar 06, 2002
ELECSYS ANTI-TG CALCHECK
K020369 · JJX
Roche Diagnostics Corp.
Immunology · 30d
Cleared Mar 06, 2002
MICROSCAN SYNERGIES PLUS
K020511 · LON
Dade Microscan, Inc.
Microbiology · 19d
Cleared Mar 05, 2002
SPL-50 SPIROLYSER
K010761 · BZG
Fim Medical
Anesthesiology · 357d
Cleared Mar 05, 2002
ANGELTOUCH VENTED IV ADMINISTRATION SET
K012189 · LHI
Angiplast Private , Ltd.
General Hospital · 236d
Cleared Mar 05, 2002
TROJAN PASSION BERRY GEL
K013433 · NUC
Armkel, LLC
Obstetrics & Gynecology · 140d
Cleared Mar 05, 2002
INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE
K013653 · HIR
Hollister, Inc.
Gastroenterology & Urology · 119d
Cleared Mar 05, 2002
CHLORINATED POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH ALOE VERA
K013774 · LZA
Supermax Sdn Bhd
General Hospital · 112d
Cleared Mar 05, 2002
SILK TOUCH POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING...
K013821 · LYY
Top Quality Mfg., Inc.
General Hospital · 109d
Cleared Mar 05, 2002
MICROAIRE 1000E SYSTEM
K014060 · HBE
Microaire Surgical Instruments, Inc.
Neurology · 85d
Cleared Mar 05, 2002
AKTINA MEDICAL PHYSICS RADIATION THERAPY WEDGES
K014081 · IYE
Aktina Medical Physics Corp.
Radiology · 84d