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
171409–171432 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 1978
EMIT MCA PROGRAM TAPE
K781081 · JQP
Instrumentation Laboratory CO
Toxicology · 92d
Cleared Sep 27, 1978
SPECTRASCAN
K781103 · DAT
Medishield, Inc.
Radiology · 86d
Cleared Sep 27, 1978
TONOMETER, DIGITON
K781105 · HKY
Ical, Inc.
Ophthalmic · 86d
Cleared Sep 27, 1978
IPPB ASSEMBLY W/NEBULIZER
K781232 · NHJ
Rtec
Anesthesiology · 68d
Cleared Sep 27, 1978
STIMULATOR, NERVE, TRANSCUTANEOUS
K781277 · GZJ
Psitron
Neurology · 64d
Cleared Sep 27, 1978
PULSED AND CONTINUOUS SHORTWAVE APPAR.
K781316 · IMJ
General Theraphysical, Inc.
Physical Medicine · 58d
Cleared Sep 27, 1978
SHORTWAVE THERAPY APPAR. CURAMED 401
K781320 · IMJ
General Theraphysical, Inc.
Physical Medicine · 58d
Cleared Sep 27, 1978
MARKII VENTIMASKS
K781325 · BYF
Vickers America Medical Corp.
Anesthesiology · 57d
Cleared Sep 27, 1978
RESURFACE PROSHESIS
K781343
Aesculap Instruments Corp.
Orthopedic · 54d
Cleared Sep 27, 1978
INTERFACE CARDIOTOMY BLOOD FILTER
K781383 · JOD
Medical, Inc.
Cardiovascular · 47d
Cleared Sep 27, 1978
ERM-101
K781407 · DRT
Cynergy
Cardiovascular · 44d
Cleared Sep 27, 1978
IMMO PHASE, THYROID HORMONE
K781409 · JLW
Corning Medical & Scientific
Chemistry · 44d
Cleared Sep 27, 1978
RIALYZE VITAMIN B-12 TEST
K781410 · CDD
Ames Div., Miles Laboratories, Inc.
Chemistry · 44d
Cleared Sep 27, 1978
GENERATORS: UDL-201B, BDL-201B, MDL-201B
K781424 · DXY
Pacesetter Systems
Cardiovascular · 41d
Cleared Sep 27, 1978
MS-2 BACTERIAL ID. SYSTEM
K781427 · JSS
Abbott Laboratories
Microbiology · 36d
Cleared Sep 27, 1978
HARRINGTON SPINE INSTRUMENTATION
K781443 · KWP
Orthopedic Equipment Co., Inc.
Orthopedic · 35d
Cleared Sep 27, 1978
OUTRIGGER DISTRACTION UNIT
K781444 · KWP
Orthopedic Equipment Co., Inc.
Orthopedic · 35d
Cleared Sep 27, 1978
C RING CLINCHER
K781446 · GEN
Orthopedic Equipment Co., Inc.
General & Plastic Surgery · 35d
Cleared Sep 27, 1978
THREADED ROD CLAMP
K781447 · GEN
Orthopedic Equipment Co., Inc.
General & Plastic Surgery · 35d
Cleared Sep 27, 1978
HARRINGTON HOOK CLAMP
K781448 · GEN
Orthopedic Equipment Co., Inc.
General & Plastic Surgery · 35d
Cleared Sep 27, 1978
HARRINGTON SPINAL ELEVATOR
K781449 · GEG
Orthopedic Equipment Co., Inc.
General & Plastic Surgery · 35d
Cleared Sep 27, 1978
DRIVERS
K781450 · GFC
Orthopedic Equipment Co., Inc.
General & Plastic Surgery · 35d
Cleared Sep 27, 1978
FLAT WRENCH
K781451 · HXS
Orthopedic Equipment Co., Inc.
Orthopedic · 35d
Cleared Sep 27, 1978
MITROPHENYL, ALKALINE PHOSPHATES
K781472 · CJE
Beckman Instruments, Inc.
Chemistry · 30d