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
83377–83400 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 11, 2000
SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS
K993954 · DKB
Beckman Coulter, Inc.
Toxicology · 50d
Cleared Jan 11, 2000
MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B...
K993971 · LLL
Micro Detect, Inc.
Immunology · 49d
Cleared Jan 11, 2000
FUJI II LC CAPSULE
K993973 · EBF
GC America, Inc.
Dental · 49d
Cleared Jan 11, 2000
MDI SM TEST
K994029 · LLL
Micro Detect, Inc.
Immunology · 46d
Cleared Jan 11, 2000
THE 4.5MM DIAMETER BICON DENTAL IMPLANT
K994037 · DZE
Bicon, Inc.
Dental · 43d
Cleared Jan 11, 2000
CORRECT TOUCH LATEX POWDERED EXAMINATION GLOVES
K994043 · LYY
Biopro (M) Sdn Bhd
General Hospital · 43d
Cleared Jan 10, 2000
PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTF
K991391 · MQL
Advanced Reproductive Technologies
Obstetrics & Gynecology · 264d
Cleared Jan 10, 2000
EIS DYNAMIC MEMORY STAPLES SYSTEM
K991962 · JDR
Groupe Lepine
Orthopedic · 214d
Cleared Jan 10, 2000
AMUKIN D
K992016 · LIF
Amuchina Intl., Inc.
Gastroenterology & Urology · 209d