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

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176,076 results
167353–167376 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 28, 1980
OTICON EARETTE HEARING AID #E17 HC
K801002 · ESD
Oticon Corp.
Ear, Nose, Throat · 30d
Cleared May 28, 1980
OTICON EARETTE HEARING AID #E17CF
K801003 · ESD
Oticon Corp.
Ear, Nose, Throat · 30d
Cleared May 28, 1980
ASL CUSTOM IN-THE-EAR HEARING AID #L
K801023 · ESD
American Sound Labs
Ear, Nose, Throat · 27d
Cleared May 28, 1980
IL MODEL 773 FLUORESCENCE LIGHT SCATTER
K801026 · JJG
Instrumentation Laboratory CO
Chemistry · 27d
Cleared May 28, 1980
MDS IMAGER
K801027
Medtronic Vascular
Radiology · 27d
Cleared May 28, 1980
CLINICAL DATA SYSTEM (CAM) MODULE
K801029 · LEJ
Adac Laboratories
Radiology · 27d
Cleared May 28, 1980
RIAUSE AUTO PROCESSOR
K801030 · JQW
Electro-Nucleonics Laboratories, Inc.
Chemistry · 27d
Cleared May 28, 1980
CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA
K801037 · LCI
Union Carbide Corp.
Chemistry · 26d
Cleared May 28, 1980
ILLUMINATED SPECULUM
K801058 · FXF
Designs For Vision, Inc.
General & Plastic Surgery · 22d
Cleared May 28, 1980
TELESONIC, SOUNDEX & GENERIC V-101
K801066 · ESD
Telesonic, Inc.
Ear, Nose, Throat · 22d
Cleared May 28, 1980
TELESONIC, GENERIC & SOUNDEX C-102
K801067 · ESD
Telesonic, Inc.
Ear, Nose, Throat · 22d
Cleared May 28, 1980
NORMCAP CD-102, CARBON DIOXIDE ANALYZER
K801083 · CCL
Instrumentarium-Datex
Anesthesiology · 21d
Cleared May 28, 1980
P-NITROPHENYL PHOSPHATE
K801086
Macomb Chemical Co.
Chemistry · 21d
Cleared May 28, 1980
J.T. BAKER NEPHELOMETER
K801089 · JQX
J.T. Baker Chemical Co.
Chemistry · 20d
Cleared May 28, 1980
ANALOR FOUR-DENTAL MODEL
K801100 · BSZ
Narco Mckesson Co.
Anesthesiology · 19d
Cleared May 28, 1980
COMPALOR-DENTAL MODEL
K801103 · BSZ
Narco Mckesson Co.
Anesthesiology · 19d
Cleared May 28, 1980
DAHLBERG HEARING AID MODEL MEH
K801114 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 16d
Cleared May 28, 1980
DAHLBERG HEARING AID MODEL MEL
K801115 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 16d
Cleared May 28, 1980
AMES TDA AMIKACIN
K801130 · KLQ
Miles Laboratories, Inc.
Toxicology · 16d
Cleared May 28, 1980
ANGIO-FLO MONITORING KIT
K801173 · KRA
Hospital Products Co.
Cardiovascular · 12d
Cleared May 28, 1980
FIBER OPTIC LIGHT SOURCE
K801176 · EQH
Aspen Laboratories, Inc.
Ear, Nose, Throat · 12d
Cleared May 28, 1980
ANESTHESIA BREATHING CIRCUITS
K801191 · CAI
Airlife, Inc.
Anesthesiology · 9d
Cleared May 28, 1980
LIBCO SUNGLASSES
K801196 · HQY
Libco Eyewear, Inc.
Ophthalmic · 13d
Cleared May 28, 1980
HOLLOW BASKET TITANIUM DENTAL IMPLANT
K801208 · ELE
Colmed, Ltd.
Dental · 8d