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
171649–171672 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 1978
BARRIER PEDIATRIC/INCISE DRAPE 450
K780839 · KKX
Surgikos, Inc.
General Hospital · 83d
Cleared Aug 14, 1978
BARRIER LAPAROTOMY SHEET 450
K780840 · KKX
Surgikos, Inc.
General Hospital · 83d
Cleared Aug 14, 1978
BARRIER MEDIUM SHEET 450
K780841 · KKX
Surgikos, Inc.
General Hospital · 83d
Cleared Aug 14, 1978
BARRIER BASIC PACK FABRIC 450
K780842 · KKX
Surgikos, Inc.
General Hospital · 84d
Cleared Aug 14, 1978
BARRIER ABDOMINAL PACK FABRIC 450
K780843 · KKX
Surgikos, Inc.
General Hospital · 84d
Cleared Aug 14, 1978
BARRIER OBSTETRICAL PACK FABRIC 450
K780844 · KKX
Surgikos, Inc.
General Hospital · 84d
Cleared Aug 14, 1978
CONCHANEOPAK A CARTRIDGE HUMIDIFIER
K780845 · BTT
Respiratory Care, Inc.
Anesthesiology · 83d
Cleared Aug 14, 1978
OP-SITE ADHESIVE DRAPES
K780853 · KKX
Acme United Corp.
General Hospital · 84d
Cleared Aug 14, 1978
BARRIER GYNECOLOGY PACK FABRIC 450
K780856 · KKX
Surgikos, Inc.
General Hospital · 82d
Cleared Aug 14, 1978
MODEL 290 OXYGEN RICH AIR SUPPLY UNIT
K780862 · CAW
The John Bunn Co.
Anesthesiology · 76d
Cleared Aug 14, 1978
CHEST ROLLS HOLDER
K780866 · FSE
Devon Industries, Inc.
General & Plastic Surgery · 76d
Cleared Aug 14, 1978
PAD HOLDER KIT
K780867 · FSE
Devon Industries, Inc.
General & Plastic Surgery · 76d
Cleared Aug 14, 1978
CHEST ROLLS
K780868 · FSE
Devon Industries, Inc.
General & Plastic Surgery · 76d
Cleared Aug 14, 1978
CELL CULTURE LINES
K780869 · KIR
Bioassay Systems Research Corp.
Toxicology · 76d
Cleared Aug 14, 1978
ENEMA BAG
K780877 · FCE
Abco Dealers, Inc.
Gastroenterology & Urology · 76d
Cleared Aug 14, 1978
DIGOXIN STANDARDS IN HUMAN SERUM
K780889 · DMP
Pcl-Ria, Inc.
Toxicology · 75d
Cleared Aug 14, 1978
LIMB COVER
K780905 · IPM
Hydro-Med Products, Inc.
Physical Medicine · 73d
Cleared Aug 14, 1978
IN VITRO TOBRAMYCIN RIA KIT
K780934 · KLB
Clinical Assays, Inc.
Microbiology · 67d
Cleared Aug 14, 1978
BIO-MONITOR AMIKACIN
K780949 · KLP
Monitor Science Corp.
Toxicology · 66d
Cleared Aug 14, 1978
BIO-MONITOR TOBRAMYCIN
K780950 · DID
Monitor Science Corp.
Toxicology · 66d
Cleared Aug 14, 1978
BIO-MONITOR GENTAMICIN
K780951 · DKD
Monitor Science Corp.
Toxicology · 66d
Cleared Aug 14, 1978
QUICKRATE REACTION RATE ANALYZER
K780972 · JJI
Olympus Corp.
Chemistry · 63d
Cleared Aug 14, 1978
ANTI-HUMAN LDL SERUM
K781015 · DFC
Icl Scientific
Immunology · 59d
Cleared Aug 14, 1978
C3PA (GBG) PROPERDIN FACTOR B
K781016 · JZH
Icl Scientific
Immunology · 59d