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
152569–152592 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 1984
PALL EC PLUS FILTER
K834380 · DTM
Pall Biomedical Products Co.
Cardiovascular · 233d
Cleared Aug 03, 1984
PALL EC PLUS FILTER W/FILTER SLEEVE
K834382 · DTM
Pall Biomedical Products Co.
Cardiovascular · 233d
Cleared Aug 03, 1984
ARTERIAL EMBOLECTOMY CATHETER
K840198 · DXE
Shiley, Inc.
Cardiovascular · 198d
Cleared Aug 03, 1984
ELECTROCARDIOGRAPH E-340
K840440 · DPS
Burdick Corp.
Cardiovascular · 184d
Cleared Aug 03, 1984
LITHIUM PACEMAKER 811-811L & 811XL
K840748 · DXY
Omikron Scientific, Ltd.
Cardiovascular · 162d
Cleared Aug 03, 1984
POROUS HYDROXYAPATITE BG200
K841201 · LYC
Interpore Intl.
Dental · 135d
Cleared Aug 03, 1984
TUBULAR HOLLOW FIBER MEMBRANE
K841476 · DTZ
American Bentley
Cardiovascular · 116d
Cleared Aug 03, 1984
SCANLAN ENDARSECTOR
K841521 · DWX
Scanlan Intl., Inc.
Cardiovascular · 113d
Cleared Aug 03, 1984
LEPTOS
K841635 · DXY
Biotronik Sales, Inc.
Cardiovascular · 106d
Cleared Aug 03, 1984
MODEL 866 PERMATHANE BIPOLAR, COAXIAL
K841739 · DTD
Pacesetter Systems
Cardiovascular · 98d
Cleared Aug 03, 1984
FASTPASS IMPLANTABLE ENDOCARDIAL PAC
K841885 · DTD
Pacesetter Systems
Cardiovascular · 88d
Cleared Aug 03, 1984
CARDIOPLEGIA RESERVOIR CAS-2000
K841938 · DTN
American Bentley
Cardiovascular · 84d
Cleared Aug 03, 1984
VAN-TEC URETERAL DILATION BALLOON CATH
K841940 · EZN
Van-Tec, Inc.
Gastroenterology & Urology · 84d
Cleared Aug 03, 1984
MODEL 110-5 & 140-8
K842005 · DXO
Camino Laboratories, Inc.
Cardiovascular · 78d
Cleared Aug 03, 1984
CENTRIMED SYSTEM 1
K842007 · KFM
Centrimed Corp.
Cardiovascular · 78d
Cleared Aug 03, 1984
IMPACT MODEL 316
K842050 · JCX
Impact Instrumentation, Inc.
General & Plastic Surgery · 73d
Cleared Aug 03, 1984
COBE EMERGENCY POWER SOURCE 43610-000
K842138 · DTQ
Cobe Laboratories, Inc.
Cardiovascular · 65d
Cleared Aug 03, 1984
SOLUTION CLARIFICATION UNIT
K842141 · KRJ
Pall Biomedical Products Co.
Cardiovascular · 65d
Cleared Aug 03, 1984
AIR SHIELDS AS461 MONITORING SYS
K842321 · DRT
Air-Shields, Inc.
Cardiovascular · 52d
Cleared Aug 03, 1984
AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN
K842328 · DEH
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 51d
Cleared Aug 03, 1984
CAVI-MED
K842581 · ELC
Cooper Lasersonics, Inc.
Dental · 31d
Cleared Aug 03, 1984
IMMUSTAPH LATEX AGGLUTINATION KIT
K842709 · LHJ
Immucell Corp.
Microbiology · 22d
Cleared Aug 03, 1984
LIMONENE
K842721 · KEM
E K Ind., Inc.
Pathology · 21d
Cleared Aug 03, 1984
SALINE, 1.3% W/O PRESERVATIVE
K842723 · KIP
E K Ind., Inc.
Pathology · 21d