Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
82513–82536 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 24, 2000
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX
K001934 · DFC
Wako Chemicals USA, Inc.
Immunology · 28d
Cleared Jul 24, 2000
SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR...
K002071 · FTL
Tissue Technologies, Inc.
General & Plastic Surgery · 17d
Cleared Jul 24, 2000
ATRIUM LITE MESH
K002093 · FTL
Atrium Medical Corp.
General & Plastic Surgery · 13d
Cleared Jul 24, 2000
ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY
K993706 · JMM
Roche Diagnostics Corp.
Chemistry · 265d
Cleared Jul 24, 2000
MACROSORBOS PROTECTIVE SHEET
K994158 · HRS
Macropore Biosurgery, Inc.
Orthopedic · 228d
Cleared Jul 23, 2000
WAKO AUTOKIT LP(A)/DADE DEMENSION
K001919 · DFC
Wako Chemicals USA, Inc.
Immunology · 30d
Cleared Jul 23, 2000
WAKO AUTOKIT LP(A)/ RA,500/1000,
K001920 · DFC
Wako Chemicals USA, Inc.
Immunology · 30d