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
115489–115512 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 04, 1992
DW243-64
K923644 · EJS
Ivoclar USA, Inc.
Dental · 106d
Cleared Nov 04, 1992
C-FIT CEMENTED HIP STEM
K923898 · JDI
Turnkey Intergration USA, Inc.
Orthopedic · 92d
Cleared Nov 04, 1992
CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL
K923909 · LZN
Orthomet, Inc.
Orthopedic · 92d
Cleared Nov 04, 1992
OPHTHALMIC FLUID DISTRIBUTION SETS
K923972 · FPK
Visitec Co.
General Hospital · 89d
Cleared Nov 04, 1992
PALABOND
K924422 · EBI
Heraeus Kulzer, Inc.
Dental · 64d
Cleared Nov 04, 1992
DENTURE PLASTIC TEETH
K924526 · ELM
Austenal, Inc.
Dental · 57d
Cleared Nov 04, 1992
PHONAK PICO-FORTE PP-SC-2 BTE HEARING INSTRUMENT
K924911 · ESD
Phonak, Inc.
Ear, Nose, Throat · 36d
Cleared Nov 04, 1992
PHONAK PICO-FORTE PPC-L-P-2 BTE HEARING INSTR
K924913 · ESD
Phonak, Inc.
Ear, Nose, Throat · 36d
Cleared Nov 04, 1992
PHONAK PICO-FORTE PPC-P-2 BTE HEARING INSTRUMENT
K924914 · ESD
Phonak, Inc.
Ear, Nose, Throat · 36d
Cleared Nov 03, 1992
VITALERT 3000 MONITORING SYSTEM
K913995 · CCK
Draeger Medical, Inc.
Anesthesiology · 424d
Cleared Nov 03, 1992
CARDIOVIT CS-100
K914970 · LOS
Schiller America, Inc.
Cardiovascular · 364d
Cleared Nov 03, 1992
KINAMED 32MM BIOCERAM-Z TOATAL HIP FEMORAL BALL
K920290 · LZO
Kinamed, Inc.
Orthopedic · 286d
Cleared Nov 03, 1992
LS100 HALOGEN EXAMINATION LIGHT, MODEL NO: 44100
K921493 · KZF
Welch Allyn, Inc.
General Hospital · 218d
Cleared Nov 03, 1992
DIGITAL BLOOD PRESSURE MONITOR MODEL #UF-101
K921627 · DXN
Showa Engineering Co., Ltd.
Cardiovascular · 211d
Cleared Nov 03, 1992
DALLA BONA BALL & SOCKEY ATTACH. SNAP TYPE PRECIS
K921764 · DZE
Implant Support Systems, Inc.
Dental · 203d
Cleared Nov 03, 1992
MEDELEC 2110 AND 2114 EEG
K922548 · GWQ
Medelec Intl. Corp.
Neurology · 155d
Cleared Nov 03, 1992
S1500 XENON LIGHT SOURCE
K922837 · HBI
Endomedix
General & Plastic Surgery · 144d
Cleared Nov 03, 1992
STETHOSCOPE COVER
K923327 · LDE
Anup Chakraborty Co.
Cardiovascular · 119d
Cleared Nov 03, 1992
DFS GENIUS BTE
K924185 · ESD
Gn Danavox, Inc.
Ear, Nose, Throat · 75d
Cleared Nov 03, 1992
PHONAK PICO-FORTE C-2 BTE HEARING INSTRUMENT
K924912 · ESD
Phonak, Inc.
Ear, Nose, Throat · 35d
Cleared Nov 02, 1992
SEHRIST VOLUME VENTILATOR, MODEL 2200B
K914607 · CBK
Sechrist Industries, Inc.
Anesthesiology · 382d
Cleared Nov 02, 1992
DGH-500 PACHYMETER
K920906 · IYO
Dgh Technology, Inc.
Radiology · 249d
Cleared Nov 02, 1992
CMS RECORD AND VERIFY
K921108 · KPQ
Computerized Medical Systems, Inc.
Radiology · 238d
Cleared Nov 02, 1992
MEDGRAPHIX INTL VR 1000 SERIES
K921381 · LMC
Medgraphix Intl.
Radiology · 224d