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
153169–153192 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 11, 1984
PORTA PAK 90
K840900 · LDD
Medical Research Laboratories, Inc.
Cardiovascular · 104d
Cleared Jun 11, 1984
SCANLAN COLORMARK SKIN MARKER
K841085 · FZZ
Scanlan Intl., Inc.
General & Plastic Surgery · 90d
Cleared Jun 11, 1984
DESERET HEPARIN COATED FLOW CATH
K841251 · DYG
Parke-Davis Co.
Cardiovascular · 77d
Cleared Jun 11, 1984
TUBE TENDER
K841296 · KRI
The Anspach Effort, Inc.
Cardiovascular · 73d
Cleared Jun 11, 1984
DESERET HEPARIN COATED FLOW DIRECTED
K841317 · DYG
Parke-Davis Co.
Cardiovascular · 70d
Cleared Jun 11, 1984
TEMPERATURE CONTROL & MONITOR
K841402 · DWC
Sams, Inc.
Cardiovascular · 69d
Cleared Jun 11, 1984
REUSEABLE NON-CONDUCTIVE FIXED Y
K841455 · CAI
Dryden Corp.
Anesthesiology · 63d
Cleared Jun 11, 1984
PRESSURE CATHETER PLACEMENT SET 50010
K841482 · DWF
Dlp, Inc.
Cardiovascular · 63d
Cleared Jun 11, 1984
MODEL 1000 APC-ANGIOPLASTY PRESSURE
K841493 · DXT
E.A. Fischione Instrument Mfg.
Cardiovascular · 62d
Cleared Jun 11, 1984
QUICK-COUNT PLUS 2
K841504 · GKL
Seragen Diagnostics, Inc.
Hematology · 62d
Cleared Jun 11, 1984
IMPACT MODEL 308
K841538 · JCX
Impact Instrumentation, Inc.
General & Plastic Surgery · 56d
Cleared Jun 11, 1984
STERILE BLOOD LANCETS
K841677 · FMK
Abco Dealers, Inc.
General & Plastic Surgery · 49d
Cleared Jun 11, 1984
HOLDER FOR BOS-10, 10S 5S
K841812 · KRI
American Bentley
Cardiovascular · 41d
Cleared Jun 11, 1984
MODIFICATION TO ACS CORONARY GUIDING
K841992 · DAO
Advanced Cardiovascular Systems, Inc.
Immunology · 47d
Cleared Jun 11, 1984
AUTOMATED EIA MICROPLATE READER EL310
K842085 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 18d
Cleared Jun 11, 1984
SPUNGARD & SURG. DRAPES-GOWNS & PACKS
K842115 · KKX
Kimberly-Clark Corp.
General Hospital · 47d
Cleared Jun 08, 1984
BIOPSY PUNCH, VARIOUS
K841008 · GEE
Premier Dental Products Co.
General & Plastic Surgery · 91d
Cleared Jun 08, 1984
ENZYMATIC CO2 DIAGNOSTIC CHEMICAL
K841664 · KHS
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 46d
Cleared Jun 08, 1984
TDX REA LDH
K841703 · CFJ
Abbott Laboratories
Chemistry · 46d
Cleared Jun 08, 1984
ZERO-G
K842120 · KIC
Steridyne Corp.
Physical Medicine · 10d
Cleared Jun 07, 1984
NITROUS OXIDE RECYCLER
K834535 · BSF
G & L Unltd.
Anesthesiology · 168d
Cleared Jun 07, 1984
GAS SUPPLY MANIFOLD SIEMENS-ELEMA AB
K840326 · CAM
Siemens Elema AB
Anesthesiology · 134d
Cleared Jun 07, 1984
KIDNEY TRANSPLANT CATHETER
K840687 · KDN
Warne Surgical Products, Ltd.
Gastroenterology & Urology · 113d
Cleared Jun 07, 1984
CONTACT LENS CASE FOR SOFT LENSES
K840692 · LRX
Optimum Manufacturers, Inc.
Ophthalmic · 112d