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
101449–101472 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 15, 1995
ANESTHESIA/RESPIRATORY FACE MASK
K953107 · BSJ
Medical Marketing Concepts
Anesthesiology · 43d
Cleared Aug 15, 1995
PIPERACILIN TAZOBACTAM 4 UG
K953223 · JWY
Ab Biodisk
Microbiology · 123d
Cleared Aug 15, 1995
CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM
K953261 · DHR
Shared Systems, Inc.
Immunology · 34d
Cleared Aug 14, 1995
OSTEONICS PS HEMI-HIP STEM SERIES
K933882 · LPH
Osteonics Corp.
Orthopedic · 734d
Cleared Aug 14, 1995
DYNA-LOK ANTERIOR PLATING SYSTEM
K936307 · MNH
Danek Group, Inc.
Orthopedic · 721d
Cleared Aug 14, 1995
SUNGLASSES
K941084 · HQY
Blue Gem Sunglasses, Inc.
Ophthalmic · 524d
Cleared Aug 14, 1995
INTEQ TFCC REPAIR SYSTEM
K941862 · HRX
Linvatec Corp.
Orthopedic · 486d
Cleared Aug 14, 1995
BX-400S
K942195 · IPF
Bloomex International, Inc.
Physical Medicine · 489d
Cleared Aug 14, 1995
BX-200 SC
K943185 · IPF
Bloomex International, Inc.
Physical Medicine · 489d
Cleared Aug 14, 1995
OSTEONICS RESTORATION CEMENTED HIP STEM SERIES
K943778 · KWL
Osteonics Corp.
Orthopedic · 377d
Cleared Aug 14, 1995
S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM II
K944321 · JWH
Joint Medical Products Corp.
Orthopedic · 346d
Cleared Aug 14, 1995
ABBOTT TEST PACK STREP A TEST
K945571 · GTZ
Abbott Laboratories
Microbiology · 280d
Cleared Aug 14, 1995
CHAL-2500
K946186 · IPF
Hogan & Hartson
Physical Medicine · 237d
Cleared Aug 14, 1995
MING-YA OPTICAL INDUSTRIALCO., LTD.
K951801 · HQY
Min-Ya Optical Industrial Co., Ltd.
Ophthalmic · 118d
Cleared Aug 14, 1995
BODYFLEX MASSAGER
K952041 · ISA
Truro'S Ent.
Physical Medicine · 105d
Cleared Aug 14, 1995
ELMED THERMO-FLUX
K952110 · GEI
Elmed, Inc.
General & Plastic Surgery · 101d
Cleared Aug 14, 1995
GLOVETEX (MULTIPLE)
K952197 · LYY
Pt Mbf Buana Multicorpora
General Hospital · 97d
Cleared Aug 14, 1995
CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN
K952360 · DDR
Princeton BioMeditech Corp.
Immunology · 103d
Cleared Aug 14, 1995
CUTINOVA CAVITY
K952526 · KMF
Beiersdorf, Inc.
General & Plastic Surgery · 74d
Cleared Aug 14, 1995
COVERSAN, ISLESAN
K952547 · KMF
Medical Device Development Co.
General & Plastic Surgery · 73d
Cleared Aug 14, 1995
ROYAL SHIELD NON-STERILE PINK COLOERED, STRAWBERRY SCENTED LATEX EXAMINATION...
K952590 · LYY
Shield Gloves Manufacturer Sdn. Bhd....
General Hospital · 70d
Cleared Aug 14, 1995
ENDOCARE ELECTROSURGICAL HANDPIECE
K952698 · GEI
Cytocare, Inc.
General & Plastic Surgery · 62d
Cleared Aug 14, 1995
OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES
K952789 · GKZ
Immunotech Corp.
Hematology · 56d
Cleared Aug 14, 1995
VISULINK 900 ARGON
K952894 · HQF
Carl Zeiss, Inc.
Ophthalmic · 52d