FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
76369–76392 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 05, 2002
ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822
K014204 · DXN
K-Jump Health Co., Ltd.
Cardiovascular · 74d
Cleared Mar 05, 2002
ASTOFLO
K020060 · BSB
Nats Corp.
Hematology · 56d
Cleared Mar 05, 2002
LASERPRO 16
K020243 · LMA
Eradlink, Inc.
Radiology · 41d
Cleared Mar 04, 2002
O-RING PROSTHETIC ATTACHMENT
K001638 · DZE
Titan Implants
Dental · 643d
Cleared Mar 04, 2002
LIFEMATE MLA MULTI-LINE ADAPTOR
K011269 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 312d
Cleared Mar 04, 2002
WRISTORE FIXATOR
K012294 · KTT
Millennium Medical Technologies, Inc.
Orthopedic · 227d
Cleared Mar 04, 2002
INTEGRAPH FLASH, MODEL CI 110
K012732 · JOJ
Steritec Products, Inc.
General Hospital · 200d
Cleared Mar 04, 2002
NEUROSPECTQUAD GAMMA CAMERA
K013353 · KPS
Nuclear Cardiology Systems, Inc.
Radiology · 146d