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
81385–81408 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 2000
NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR WHITE
K001836 · LZA
Shanghai Poseidon Plastic Products...
General Hospital · 40d
Cleared Jul 26, 2000
OPTICAL TRACKING SYSTEM (OTS)
K001950 · HAW
Radionics, Inc.
Neurology · 29d
Cleared Jul 26, 2000
POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM...
K001959 · KGO
Hartalega Sdn Bhd
General Hospital · 29d
Cleared Jul 26, 2000
TRI-LOCK HIP STEM
K001982 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 27d
Cleared Jul 26, 2000
BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATHETERS
K002033 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 21d
Cleared Jul 26, 2000
GASTRIC LAVAGE VALVE
K990365 · KNT
T-Med Vac Corporation
Gastroenterology & Urology · 537d
Cleared Jul 25, 2000
MEDSCOPE
K001314 · HEX
All-Pro Imaging Corp.
Obstetrics & Gynecology · 90d
Cleared Jul 25, 2000
NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW
K001323 · MRW
Nuvasive, Inc.
Orthopedic · 90d
Cleared Jul 25, 2000
ULTIMATE N-DEX POWER FREE NITRILE EXMINATION GLOVE (TESTED FOR USE WITH...
K001375 · LZA
Best Manufacturing Company
General Hospital · 85d
Cleared Jul 25, 2000
BLAINE SCARCARE PATCH
K001608 · MDA
Blaine Labs, Inc.
General & Plastic Surgery · 62d
Cleared Jul 25, 2000
SL-PLUS AND SLR-PLUS STEMS
K001942 · LWJ
Plus Orthopedics
Orthopedic · 29d
Cleared Jul 25, 2000
MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT
K001957 · KRO
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Jul 25, 2000
COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES
K001989 · JDC
Zimmer, Inc.
Orthopedic · 26d
Cleared Jul 25, 2000
A&D MEDICAL LIFESOURCE UB-401PC & UB-401 DIGITAL BLOOD PRESSURE MONITORS
K002115 · DXN
A&D Engineering, Inc.
Cardiovascular · 12d
Cleared Jul 24, 2000
ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15
K000580 · MQN
KLS-Martin L.P.
Dental · 153d
Cleared Jul 24, 2000
RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY
K001032 · CHH
Otsuka Pharmaceutical Co., Ltd.
Chemistry · 116d
Cleared Jul 24, 2000
BONUS MECHANICAL WHEELCHAIR
K001391 · IOR
Bonus Ent. Corp.
Physical Medicine · 83d
Cleared Jul 24, 2000
SURGITRON IEC II
K001407 · GEI
Ellman Intl., Inc.
General & Plastic Surgery · 81d
Cleared Jul 24, 2000
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFOPRISTIN)
K001558 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 66d
Cleared Jul 24, 2000
MODEL CGS TILT SEATING SYSTEM FOR POWER WHEELCHAIRS
K001777 · ITI
Invacare Corp.
Physical Medicine · 41d
Cleared Jul 24, 2000
SHERPA/KODIAK CUB MOBILITY SYSTEM (MANUAL WHEELCHAIR)
K001890 · IOR
Otto Bock Orthopaedische Industrie, Kg.
Physical Medicine · 33d
Cleared Jul 24, 2000
WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA
K001929 · DFC
Wako Chemicals USA, Inc.
Chemistry · 28d
Cleared Jul 24, 2000
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET
K001931 · DFC
Wako Chemicals USA, Inc.
Immunology · 28d
Cleared Jul 24, 2000
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO
K001933 · DFC
Wako Chemicals USA, Inc.
Immunology · 28d