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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
137185–137208 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 18, 1988
TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD
K880215 · KWP
Warsaw Orthopedic, Inc.
Orthopedic · 30d
Cleared Feb 18, 1988
ARTHROBOT(TM) LOWER LIMB POSITIONER
K880227 · FQO
Andronic Devices, Ltd.
General & Plastic Surgery · 29d
Cleared Feb 18, 1988
WEHBE ARM HOLDER
K880265 · FWZ
Orthopedic Systems, Inc.
General & Plastic Surgery · 27d
Cleared Feb 18, 1988
MULTI-ENZYME LINEARITY SOLUTION
K880266 · JJT
Verichem Laboratories, Inc.
Chemistry · 27d
Cleared Feb 18, 1988
LIMA-LTO. SEM MODULAR EXTERNAL STABLIZER
K880282 · JEC
Lima-Lto, Inc.
Orthopedic · 28d
Cleared Feb 18, 1988
HOOK PUNCH FORCEPS FOR ARTHROSCOPY
K880331 · HRX
Kibbutz Gilgal Medical C/O Toam...
Orthopedic · 23d
Cleared Feb 18, 1988
SILASTIC NASAL IMPLANT S-TYPE
K880405 · FZE
Dow Corning Wright
General & Plastic Surgery · 20d
Cleared Feb 18, 1988
MICROTRAK HSV CULTURE IDENTIFICATION TEST
K880436 · GQN
Syva Co.
Microbiology · 16d
Cleared Feb 18, 1988
PEDIATRIC AIRWAY MEASUREMENT SYSTEM & P.A.M.S.
K880441 · FTY
Plane Iii, Inc.
General & Plastic Surgery · 16d
Cleared Feb 17, 1988
ORTHO. GAS INSUFFLATOR MODEL IN-2 FOR ARTHRO. SURG
K873331 · HRX
Directed Energy, Inc.
Orthopedic · 182d
Cleared Feb 17, 1988
RRT TOTAL IGE TEST KIT
K874541 · DGC
Incstar Corp.
Immunology · 106d
Cleared Feb 17, 1988
SPECTRON EF ACETABULAR COMPONENT
K874619 · JDI
Richards Medical Co., Inc.
Orthopedic · 100d
Cleared Feb 17, 1988
PERMCATH INSERTION TRAY
K874633 · LFJ
Quinton, Inc.
Gastroenterology & Urology · 100d
Cleared Feb 17, 1988
ACS 0.025-IN HI-TORQ MODIF J/STAND TELESC GUIDEWIR
K874776 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 90d
Cleared Feb 17, 1988
FLIPSCREEN QAT
K874802 · DHB
Alerchek, Inc.
Immunology · 86d
Cleared Feb 17, 1988
MIRACLE EAR MODEL BP BEHIND-THE-EAR HEARING AID
K874830 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 85d
Cleared Feb 17, 1988
ACUSON I7505 TRANSDUCER FOR INTRACAVITARY APPLICA.
K874860 · ITX
Acuson Computed Sonography
Radiology · 82d
Cleared Feb 17, 1988
MODEL 35300 TRACKER(TM) THERAPY BEAM EVALUATOR
K874893 · IYE
Keithley Instruments, Inc.
Radiology · 78d
Cleared Feb 17, 1988
MAT (TM) MICROALBUMIN TEST
K875161 · DCF
Wampole Laboratories
Immunology · 64d
Cleared Feb 17, 1988
PLUS TOTAL KNEE SYSTEM, POLY TIBIAL PEG
K875201 · JWH
Orthomet, Inc.
Orthopedic · 61d
Cleared Feb 17, 1988
DANNINGER ORTHOPAEDIC AWL
K875223 · HWJ
Danninger Medical Technology, Inc.
Orthopedic · 57d
Cleared Feb 17, 1988
GULLSORB IGG INACTIVATION REAGENT
K875254 · DEW
Gull Laboratories, Inc.
Immunology · 57d
Cleared Feb 17, 1988
TOTAL IGE IMMUNO RESPONSE TEST (IRT(R))
K875274 · DHB
Incstar Corp.
Immunology · 55d
Cleared Feb 17, 1988
QM300 CALIBRATOR B PACK
K875282 · JIX
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 55d