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
115441–115464 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 06, 1992
ANTERIOR CERVICAL PLATE SYSTEM
K922087 · KWQ
Sofamor Danek Mfg., Inc.
Orthopedic · 186d
Cleared Nov 06, 1992
A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXT
K922434 · LJT
Therex Corp.
General Hospital · 168d
Cleared Nov 06, 1992
OBALON COVER
K923173 · FMW
Turnsoft, Inc.
General Hospital · 129d
Cleared Nov 06, 1992
MYOGLOBIN ELISA TEST KIT
K923195 · DDR
Immuno Diagnostic Center, Inc.
Immunology · 129d
Cleared Nov 06, 1992
BENDEREV DRILL GUIDE
K923776 · HXY
Neimark Labs, Inc.
Orthopedic · 101d
Cleared Nov 06, 1992
MODEL 25 THERAPEUTIC ULTRASOUND -- MODIFIED
K923797 · IMG
Rich-Mar Corp.
Physical Medicine · 101d
Cleared Nov 06, 1992
EEC-1 PACKAGE
K923819 · ILQ
Med Labs, Inc.
Physical Medicine · 99d
Cleared Nov 06, 1992
IF-II (TM), MODEL 7200
K923914 · IPF
Medical Devices, Inc.
Physical Medicine · 98d
Cleared Nov 06, 1992
SAT PAD
K923948 · LNH
Alliance Pharmaceutical Corp.
Radiology · 93d
Cleared Nov 06, 1992
INTRAVASCULAR GUIDE WIRE AND EXTENSION WIRE
K924009 · DQX
Pilot Cardiovascular Systems, Inc.,...
Cardiovascular · 88d
Cleared Nov 06, 1992
DELUXE ELECTRIC COMBINATION TILT TABLE
K924019 · INQ
Midland Mfg. Co.
Physical Medicine · 87d
Cleared Nov 06, 1992
OTO-BRITE HANDLE
K924025 · ERA
Jedmed Instrument Co.
Ear, Nose, Throat · 87d
Cleared Nov 06, 1992
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (NAIL)
K924471 · JGS
Eastman Kodak Company
Chemistry · 65d
Cleared Nov 06, 1992
SYSTEMATE PLUS TRIGLYCERIDE-GLYCEROL BLANKED TEST
K924573 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 57d
Cleared Nov 06, 1992
NOVA 12 ANALYZER, MODIFICATION
K924743 · CGA
Nova Biomedical Corp.
Chemistry · 53d
Cleared Nov 06, 1992
NOVA 13 ANALYZER, MODIFICATION
K924864 · CGZ
Nova Biomedical Corp.
Chemistry · 56d
Cleared Nov 06, 1992
AAHS HEARING AID
K925103 · ESD
American Hearing Systems, Inc.
Ear, Nose, Throat · 29d
Cleared Nov 05, 1992
PXI URCD
K913435 · KPR
Brotherston/Pxi
Radiology · 462d
Cleared Nov 05, 1992
PXI PNEUMATIC COMPRESSION PADDLE
K913436 · IZG
Brotherston/Pxi
Radiology · 462d
Cleared Nov 05, 1992
MULTILASE 2100 C, 2100 D
K913917 · GEX
Teknomed, Inc.
General & Plastic Surgery · 429d
Cleared Nov 05, 1992
LIFESHIELD ANESTHESIA SET
K913982 · FPA
Abbott Laboratories
General Hospital · 427d
Cleared Nov 05, 1992
ELECTROSURGICAL UNITS ESU 30, 70, 70 B, 70 DIGITAL
K915731 · GEI
Elmed, Inc.
General & Plastic Surgery · 321d
Cleared Nov 05, 1992
MULTILASE 2500 A
K920708 · GEX
Teknomed, Inc.
General & Plastic Surgery · 261d
Cleared Nov 05, 1992
LENSONIC(TM) CONTACT LENS CARE ACCESSORY
K921615 · LYL
Personal Professional Products, Inc.
Ophthalmic · 213d