FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
75865–75888 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 04, 2002
CARBODISSECTING ENDOSCOPE
K013680 · GEI
Endo Surgical Devices, Inc.
General & Plastic Surgery · 117d
Cleared Mar 04, 2002
INFRARED EAR THERMOMETER, MODEL DX-707
K013876 · FLL
Jawon Medical Co., Ltd.
General Hospital · 101d
Cleared Mar 04, 2002
ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890
K014002 · KOB
Fortune Medical Instrument Corp.
Gastroenterology & Urology · 90d
Cleared Mar 04, 2002
MRI LINE MARKER
K014022 · IYE
I.Z.I. Corp.
Radiology · 88d
Cleared Mar 04, 2002
MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT)
K014044 · HOQ
Notal Vision, Inc.
Ophthalmic · 87d
Cleared Mar 04, 2002
LATEXX MANUFACTURING NON-CHLORINATED, POLYMER COATED, POWDER-FREE RUBBER...
K014087 · LYY
Latexx Manufacturing Sdn.Bhd.
General Hospital · 83d
Cleared Mar 04, 2002
STAURENGHI WIDE FIELD SCANNING LASER LENS
K014170 · HJK
Ocular Instruments, Inc.
Ophthalmic · 74d
Cleared Mar 04, 2002
SONOREAL 3D SYSTEM
K020068 · IYO
Bio Medi Com
Radiology · 54d
Cleared Mar 04, 2002
AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP...
K020137 · EGS
Aseptico, Inc.
Dental · 47d