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
156169–156192 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 14, 1983
ABBOTT IGE EIA
K832360 · DGC
Abbott Laboratories
Chemistry · 88d
Cleared Oct 14, 1983
CONCEPT T-TUBE
K832361 · ETD
Concept, Inc.
Ear, Nose, Throat · 88d
Cleared Oct 14, 1983
DONALDSON-TYPE VENT TUBE
K832362 · ETD
Concept, Inc.
Ear, Nose, Throat · 88d
Cleared Oct 14, 1983
LIQUID CHROMATOGRAPH 1090 SERIES
K832375 · LDM
Hewlett-Packard Co.
Toxicology · 88d
Cleared Oct 14, 1983
EASYTOUCH TROMBOPLASTIN REAGENT
K832427 · GJS
Worthington Diagnostic Systems
Chemistry · 84d
Cleared Oct 14, 1983
URO-TEX MALE EXTERNAL CATHETER
K832450 · KNX
Sierra Laboratories, Inc.
Gastroenterology & Urology · 80d
Cleared Oct 14, 1983
PERCUTANEOUS TRACHEOSTOMY DEVICE
K832498 · BTO
Frederic J. Toye, M.D.
Anesthesiology · 79d
Cleared Oct 14, 1983
CEFUROXIME 30 MCG SENSI-DISC
K832515 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 78d
Cleared Oct 14, 1983
CUSTOM KWIK SET AND/OR PAK
K832517 · JOL
Norton Texas Medical Products
General Hospital · 78d
Cleared Oct 14, 1983
MARK V HIGH VOLTAGE GALVANIC STIMULATORR
K832546 · IPF
Orthion Corp.
Physical Medicine · 77d
Cleared Oct 14, 1983
MOUTH-TO-MOUTH SHIELD APPLICATOR
K832590 · LAE
Mem, Inc.
Toxicology · 73d
Cleared Oct 14, 1983
TOP DISPOSABLE PLASTIC SYRINGES
K832621 · FMF
Top Surgical Manufacturers Co.
General Hospital · 71d
Cleared Oct 14, 1983
WINGED INFUSION SET
K832622 · FPA
Top Surgical Manufacturers Co.
General Hospital · 71d
Cleared Oct 14, 1983
TOP DISPOS. INFUSION SET/HEMODIALY
K832623 · KOC
Top Surgical Manufacturers Co.
Gastroenterology & Urology · 71d
Cleared Oct 14, 1983
TOP STERILE DISPOS. HYPODERMIC NEEDLES
K832626 · GAA
Top Surgical Manufacturers Co.
General & Plastic Surgery · 71d
Cleared Oct 14, 1983
FRAZIER SUCTION INSTRUMENT-DISPOS
K832636 · GEA
Pilling Co.
General & Plastic Surgery · 71d
Cleared Oct 14, 1983
CEFUROXIME 30MCG. SUSCEP DISK
K832653 · JTN
General Diagnostics
Microbiology · 67d
Cleared Oct 14, 1983
NEPHROSS PRESTO
K832666 · KOC
Organon Teknika Corp.
Gastroenterology & Urology · 66d
Cleared Oct 14, 1983
MICRO-EDGE DISPOSABLE BLADES
K832680 · KDC
Micromedics, Inc.
General & Plastic Surgery · 66d
Cleared Oct 14, 1983
MULTIPLE MANUAL SURGICAL INSTRUMENTS
K832686 · HTO
Hirata Sangyo Co. USA, Inc.
Orthopedic · 73d
Cleared Oct 14, 1983
PARAMAX CALCIUM REAGENT-GLUTAMY-TRANS
K832708 · CIC
American Dade
Chemistry · 63d
Cleared Oct 14, 1983
KEMTEK 400 RIA GAMMA COUNTER
K832734 · JJJ
Kemble Instruments, Inc.
Chemistry · 71d
Cleared Oct 14, 1983
ALBUMIN REAGENT SET
K832747 · CIX
Biorent Diagnostic, Inc.
Chemistry · 60d
Cleared Oct 14, 1983
COMPUR* EASYTOUCH TOTAL BILIRUBIN
K832748 · CIG
Worthington Diagnostic Systems
Chemistry · 60d