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
165481–165504 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 15, 1981
SURGITEK MEDI-LOOPS
K803156 · KDC
Medical Engineering Corp.
General & Plastic Surgery · 34d
Cleared Jan 15, 1981
IRRADIATED BOUNDARY DEVICES
K803158 · FYA
The Buckeye Cellulose Corp.
General Hospital · 55d
Cleared Jan 15, 1981
GAUZE SPONGES
K803172 · EFQ
Worldwide Surgical Gauze
General & Plastic Surgery · 31d
Cleared Jan 15, 1981
GAUZE SPONGES
K803188 · GDY
Abco Dealers, Inc.
General & Plastic Surgery · 30d
Cleared Jan 15, 1981
IRRIGATION SET W/PISTON SYRINGE
K803198 · FMF
Walpak Co.
General Hospital · 29d
Cleared Jan 15, 1981
SUTURE REMOVAL KIT
K803199 · KDD
Walpak Co.
General & Plastic Surgery · 29d
Cleared Jan 15, 1981
REGULATOR, OXYGEN MECHANICAL
K803207 · CAN
Timeter Instrument Corp.
Anesthesiology · 28d
Cleared Jan 15, 1981
ACMI BIPOLAR HEMOSTATIC ELECTRODE
K803214 · FEH
American Cystocope Makers, Inc.
Gastroenterology & Urology · 28d
Cleared Jan 15, 1981
CORDIS HAKIM ASCITES VALVE SYSTEM
K803258 · KPM
Cordis Corp.
Gastroenterology & Urology · 23d
Cleared Jan 15, 1981
T3 RIABEAD DIAGNOSTIC KIT
K803261 · CDP
Abbott Laboratories
Chemistry · 22d
Cleared Jan 15, 1981
CAPSULE DENTAL AMALGAM
K803269
Dentsply Intl.
Dental · 17d
Cleared Jan 15, 1981
COLD/HOT PACK
K803299 · IME
W.G. Whitney Corp.
Physical Medicine · 16d
Cleared Jan 15, 1981
PENTAX UPPER G.I. FIBERSCOPE, #FG-34
K810007 · GDB
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 10d
Cleared Jan 15, 1981
FOOT BATHS & HAND MASSAGERS
K810034 · ILJ
Associated Mills, Inc.
Physical Medicine · 9d
Cleared Jan 14, 1981
ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE
K802975 · EBF
Dentsply Intl.
Dental · 54d
Cleared Jan 14, 1981
ELIPAR LIGHT SOURCE
K803209 · EBZ
Espe-Premier Sales Co.
Dental · 27d
Cleared Jan 14, 1981
VISIO-DISPERS
K803227 · EBF
Espe-Premier Sales Co.
Dental · 26d
Cleared Jan 14, 1981
CERAMCO PORCELAIN
K803310 · EIH
Johnson & Johnson Professionals, Inc.
Dental · 12d
Cleared Jan 14, 1981
ORTHODONTIC BRACKET
K803316 · EJF
Orec Corp.
Dental · 15d
Cleared Jan 14, 1981
POST-AURICULAR HEARING AID (#PE830)
K810030 · ESD
Hc Electronics
Ear, Nose, Throat · 8d
Cleared Jan 13, 1981
DATASCOPE/AVCO CONNECTOR
K801601 · DSP
Datascope Corp.
Cardiovascular · 183d
Cleared Jan 13, 1981
PERCOR DATASCOPE INTRA-AORTIC BALLOON
K802167 · DSP
Datascope Corp.
Cardiovascular · 127d
Cleared Jan 13, 1981
TECNOL O.R. TOURNIQUET COVER
K802850 · EYR
Tecnol New Jersey Wound Care, Inc.
General & Plastic Surgery · 62d
Cleared Jan 13, 1981
FOGARTY BALLON ANGIOPLASTY CATHETERS
K803057 · LIT
American Edwards Laboratories
Cardiovascular · 42d