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
83881–83904 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 2000
AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE
K992719 · KNT
Amsino Intl., Inc.
Gastroenterology & Urology · 153d
Cleared Jan 12, 2000
LEMAITRE BILIARY CATHETER
K992941 · LQR
Vascutech, Inc.
Gastroenterology & Urology · 134d
Cleared Jan 12, 2000
SEGMENTED VAGINAL APPLICATOR
K993472 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 90d
Cleared Jan 12, 2000
INNOVATIVE GLOVES LATEX EXAMINATION GLOVES POWDERFREE WITH PROTEIN LABELING...
K993567 · LYY
Innovative Gloves Co;, Ltd.
General Hospital · 83d
Cleared Jan 12, 2000
GUTHRIE PRIME PRE-POWDERED PATIENT LATEX EXAMINATION GLOVE
K993793 · LYY
Guthrie Medicare Products (Melaka)...
General Hospital · 64d
Cleared Jan 12, 2000
CONVERTORS SURGICAL DRAPES
K993795 · KKX
Allegiance Healthcare Corp.
General Hospital · 64d
Cleared Jan 12, 2000
ENA PROFILE ELISA TEST SYSTEM
K993839 · LLL
Trinity Biotech USA
Immunology · 61d
Cleared Jan 12, 2000
SHANGHAI GLOVMAX ENTERPRISE CO., LTD. PRE-POWDERED VINYL PATIENT EXAMINATION...
K993859 · LYZ
Shanghai Glovmax Enterprise Co.,Ltd
General Hospital · 58d
Cleared Jan 12, 2000
SHANGHAI GLOVMAX ENTERPRISE CO, LTD., POWDER-FREE VINYL PATIENT EXAMINATION...
K993880 · LYZ
Shanghai Glovmax Enterprise Co.,Ltd
General Hospital · 58d
Cleared Jan 12, 2000
FLIPO XENON CURING LIGHT
K994028 · EBZ
Lokki
Dental · 47d
Cleared Jan 12, 2000
ADMIRA
K994056 · EBF
Voco GmbH
Dental · 43d
Cleared Jan 12, 2000
SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR
K994325 · JIS
Beckman Coulter, Inc.
Chemistry · 21d
Cleared Jan 11, 2000
DENTAL HANDPIECE
K971732 · EFB
Pauline M. Nicholls
Dental · 977d
Cleared Jan 11, 2000
HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682
K990856 · BZD
Bird Products Corp.
Anesthesiology · 302d
Cleared Jan 11, 2000
FROLOV'S RESPIRATION TRAINING DEVICE, FRTD-01
K992256 · BWF
Intercontinental New Technologies, Inc.
Anesthesiology · 189d
Cleared Jan 11, 2000
3M TR SYSTEM
K992489 · EIH
3M Company
Dental · 169d
Cleared Jan 11, 2000
BRAINLAB STEREOTACTIC ARC
K992916 · HAW
Brainlab
Neurology · 134d
Cleared Jan 11, 2000
BEHRING COAGULATION SYSTEM (BCS)
K992959 · JPA
Dade Behring, Inc.
Hematology · 131d
Cleared Jan 11, 2000
FLIPPER DETACHABLE EMBOLIZATION COIL
K993455 · KRD
Cook, Inc.
Cardiovascular · 90d
Cleared Jan 11, 2000
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z43
K993460 · DXN
Rossmax International , Ltd.
Cardiovascular · 90d
Cleared Jan 11, 2000
DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE
K993465 · HRS
Depuy, Inc.
Orthopedic · 90d
Cleared Jan 11, 2000
SYNEA - LS LOW-SPEED HANDPIECE
K993526 · EFB
A-Dec, Inc.
Dental · 85d
Cleared Jan 11, 2000
SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES
K993664 · LYZ
Top Glove Sdn. Bhd.
General Hospital · 74d
Cleared Jan 11, 2000
MDI RF TEST
K993843 · DHR
Micro Detect, Inc.
Immunology · 60d