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
141793–141816 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 08, 1987
EASY-TEST QUINIDINE ITEM NO. 67---/95
K864607 · LBZ
Em Diagnostic Systems, Inc.
Toxicology · 45d
Cleared Jan 08, 1987
MODEL FORCE 4B ELECTROSURGICAL GENERATOR
K864675 · GEI
Valleylab, Inc.
General & Plastic Surgery · 37d
Cleared Jan 08, 1987
AMOENA BREAST FORMS
K864785 · GBI
Coloplast Corp.
General & Plastic Surgery · 31d
Cleared Jan 08, 1987
PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT
K864786 · GBI
Coloplast Corp.
General & Plastic Surgery · 31d
Cleared Jan 08, 1987
CK 5000 SERIES, ACE BANDAGE/ESMARK BANDAGE
K864816
Currie Medical Specialties, Inc.
General & Plastic Surgery · 30d
Cleared Jan 08, 1987
MODEL FORCE 100 BIPOLAR ELECTROSURGICAL GENERATOR
K864851 · GEI
Valleylab, Inc.
General & Plastic Surgery · 29d
Cleared Jan 07, 1987
VNA OPTICAL CORRELATOR
K861514 · LLZ
Vna Systems, Inc.
Radiology · 259d
Cleared Jan 07, 1987
ARTHROPHONOMETER
K862286 · NFQ
Arthrotek, Inc.
Dental · 205d
Cleared Jan 07, 1987
FYODOROV COLLAGEN CORNEAL SHIELD
K862315 · MOE
Medical Technology Development Corp.
Ophthalmic · 203d
Cleared Jan 07, 1987
EZ-SCREEN: CANNABINOID
K862916 · KLT
Environmental Diagnostics, Inc.
Toxicology · 159d
Cleared Jan 07, 1987
THE OB-GYN CONCEPTS VAGINAL ASPIRATOR
K863610 · KOH
Ob/Gyn Concepts, Ltd.
Obstetrics & Gynecology · 113d
Cleared Jan 07, 1987
MINOLTA/MARQUEST PULSOX-7 OXYGEN SATURATION MONIT.
K863918 · DQA
Marquest Medical Products, Inc.
Anesthesiology · 91d
Cleared Jan 07, 1987
MICRO-VENT
K864321 · DZE
Core-Vent Corp.
Dental · 65d
Cleared Jan 07, 1987
REMBRANDT PORCELAIN TINTING KIT
K864346 · EBF
Den-Mat Corp.
Dental · 64d
Cleared Jan 07, 1987
DUOCEPH
K864527 · IWY
Gary E. Hall, Dds
Radiology · 51d
Cleared Jan 07, 1987
EASY-TEST PRIMIDONE ITEM NO. 67---/95
K864554 · DIP
Em Diagnostic Systems, Inc.
Toxicology · 49d
Cleared Jan 07, 1987
TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP
K864677 · JLW
Serono Diagnostics, Inc.
Chemistry · 36d
Cleared Jan 07, 1987
EMDS TM PHENYTOIN (PTN) TESTPACK, ITEM #67676/95
K864925 · DIP
Em Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Jan 07, 1987
EMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95
K864926 · DLZ
Em Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Jan 06, 1987
SPERM CAPACITATION MEDIUM
K861188 · HDR
Irvine Scientific
Obstetrics & Gynecology · 281d
Cleared Jan 06, 1987
ANGIOTOPO CATHETER
K861241 · DQO
Houston Biomedical, Inc.
Cardiovascular · 279d
Cleared Jan 06, 1987
MODEL 436-01 BIOPORE IMPLANTABLE PACING LEAD
K862051 · DTB
Intermedics, Inc.
Cardiovascular · 222d
Cleared Jan 06, 1987
CANWEST OVU-BLUE
K862055 · CEP
Canwest Medictex, Inc.
Chemistry · 221d
Cleared Jan 06, 1987
MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH
K863153 · DXG
Ocg Technology, Inc.
Cardiovascular · 144d