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
116425–116448 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 06, 1992
BTE HEARING AID PERSONIC 410
K923490 · ESD
Oticon Corp.
Ear, Nose, Throat · 22d
Cleared Aug 06, 1992
BTE HEARING AID PERSONIC 425
K923491 · ESD
Oticon Corp.
Ear, Nose, Throat · 23d
Cleared Aug 05, 1992
POLYCATH #WMC-900
K912270 · DQO
Worldwide Medical
Cardiovascular · 441d
Cleared Aug 05, 1992
SUNTIGER/EAGLE 475/AVIAN-AVIAN/PST 475 SUNGLASSES
K914473 · HQY
Biomedical Optics Co. of America, Inc.
Ophthalmic · 302d
Cleared Aug 05, 1992
FIBRINOSTIKA TDP MICROELISA SYSTEM
K915698 · DAP
Organon Teknika Corp.
Hematology · 226d
Cleared Aug 05, 1992
INSTASCAN
K920204 · LNH
Advanced Nmr Systems, Inc.
Radiology · 202d
Cleared Aug 05, 1992
OPHTHALMIC SPONGES
K920354 · HOZ
Ultracell Medical Technologies, Inc.
Ophthalmic · 191d
Cleared Aug 05, 1992
BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL
K920525 · DIS
Biotrack, Inc.
Toxicology · 183d
Cleared Aug 05, 1992
INTRAMEDULARY FIXATION ROD
K920666 · HSB
Acu Med, Inc.
Orthopedic · 174d
Cleared Aug 05, 1992
OIC MODEL J4 TMJ CPM
K921348 · BXB
Lm Product Design, Inc.
Physical Medicine · 139d
Cleared Aug 05, 1992
CYLINDER OF GAS, CAN OF GAS (CC12F2)
K921617 · HKX
Bio-Rad
Ophthalmic · 121d
Cleared Aug 05, 1992
IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064
K922047 · DGC
Medix Biotech, Inc.
Immunology · 96d
Cleared Aug 05, 1992
CITSCOPE (MODEL EXTENSIONS)
K922144 · HRX
Citation Medical Corp.
Orthopedic · 91d
Cleared Aug 05, 1992
ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREW
K922322 · HWC
Alphatec Mfg., Inc.
Orthopedic · 79d
Cleared Aug 05, 1992
ACCU-STAR
K922446 · EJS
J.F. Jelenko & Co., Inc.
Dental · 75d
Cleared Aug 05, 1992
BENCHMARK III
K922447 · EJS
J.F. Jelenko & Co., Inc.
Dental · 75d
Cleared Aug 05, 1992
BENCHMARK I
K922448 · EJS
J.F. Jelenko & Co., Inc.
Dental · 75d
Cleared Aug 05, 1992
PA-400
K922449 · EJS
J.F. Jelenko & Co., Inc.
Dental · 75d
Cleared Aug 05, 1992
BENCHMARK C
K922450 · EJS
J.F. Jelenko & Co., Inc.
Dental · 75d
Cleared Aug 05, 1992
LEGACY-XT
K922451 · EJS
J.F. Jelenko & Co., Inc.
Dental · 75d
Cleared Aug 05, 1992
ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS
K922823 · CGN
Bio-Rad Laboratories, Inc.
Chemistry · 55d
Cleared Aug 05, 1992
AQUA MERON
K922854 · EMA
Voco GmbH
Dental · 51d
Cleared Aug 05, 1992
HEALTHPAK UTILITY SOX BARRIERS
K923306 · KLC
Healthpak, Inc.
Dental · 89d
Cleared Aug 04, 1992
STATIM CASSETT AUTOCLAVE, MODIFICATION
K915054 · FLE
Scican
General Hospital · 274d