FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
133465–133488 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 1988
ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE
K884862 · GES
Anchor Products Co.
General & Plastic Surgery · 36d
Cleared Dec 27, 1988
BUMPY MEDICAL MASSAGE MAT
K884907 · LYG
Medical Flotation Systems, Inc.
Physical Medicine · 34d
Cleared Dec 27, 1988
ULTRAFLOTATION MEDICAL WHEELCHAIR
K884908 · INF
Medical Flotation Systems, Inc.
Physical Medicine · 34d
Cleared Dec 27, 1988
CARDIOCAP(TM) CTO-104 MONITOR
K884956 · DPS
Datex Division Instrumentarium Corp.
Cardiovascular · 28d
Cleared Dec 27, 1988
MODIFIED Q-SERIES OF TREADMILLS
K885062 · IOL
Quinton, Inc.
Physical Medicine · 21d
Cleared Dec 27, 1988
1600 LIGHT TOUCH CONTROL
K885103 · ITI
Rolcontrol Products, Co., Inc.
Physical Medicine · 15d
Cleared Dec 27, 1988
LAYDOWN ARM SUPPORT MECHANISM
K885104 · KNN
Rolcontrol Products, Co., Inc.
Physical Medicine · 15d
Cleared Dec 27, 1988
SLIDING ARM SUPPORT
K885105 · KNN
Rolcontrol Products, Co., Inc.
Physical Medicine · 15d
Cleared Dec 27, 1988
REMOVABLE BATTERY POWER SYSTEM
K885106 · KNN
Rolcontrol Products, Co., Inc.
Physical Medicine · 15d
Cleared Dec 23, 1988
MEDITRODE KIT
K882554 · EGJ
Life-Tech Intl., Inc.
Physical Medicine · 185d
Cleared Dec 22, 1988
STERA DISPOSABLE SYRINGES
K881791 · FMF
Excel U.S.A.
General Hospital · 240d
Cleared Dec 22, 1988
HEMODIALYSIS CONCENTRATES
K883068 · KPO
Dove Medical Supplies
Gastroenterology & Urology · 155d
Cleared Dec 22, 1988
AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT
K883123 · CEC
Amersham Corp.
Chemistry · 149d
Cleared Dec 22, 1988
ORTHO* SYPHILIS-M ANTIBODY ELISA TEST
K883938 · LIP
Ortho Diagnostic Systems, Inc.
Microbiology · 94d
Cleared Dec 22, 1988
ORTHO* SYPHILIS-G ANTIBODY ELISA TEST
K883939 · LIP
Ortho Diagnostic Systems, Inc.
Microbiology · 94d
Cleared Dec 22, 1988
HEMORX COLD PACK
K883984 · LKX
Bio-Dyne, Inc.
Gastroenterology & Urology · 93d
Cleared Dec 22, 1988
PMT MODEL 1110-5 PMT PERITONEAL CATHETER
K884036 · JXG
Pmt Corp.
Neurology · 87d
Cleared Dec 22, 1988
INDENTEC DRILL RA #1
K884187 · DZA
Phillip C. Crawford, D.D.S.
Dental · 78d
Cleared Dec 22, 1988
LEVINIUM
K884257 · EJH
Ticomet Engineering & Consulting
Dental · 72d
Cleared Dec 22, 1988
FLEXIFLO INTRODUCER (DIRECT STICK) GASTROSTOMY KIT
K884275 · KNT
Abbott Laboratories
Gastroenterology & Urology · 71d
Cleared Dec 22, 1988
AD POST
K884277 · ELR
J. Morita USA, Inc.
Dental · 71d
Cleared Dec 22, 1988
MODEL WC-102 NEWBORN BED & EQUIPMENT CABINET
K884280 · FMT
Gempco, Inc.
General Hospital · 71d
Cleared Dec 22, 1988
MODEL WC-107 MOBILE NEWBORN BED
K884283 · FMT
Gempco, Inc.
General Hospital · 71d
Cleared Dec 22, 1988
MODEL WC-115 MOBILE BASSINET
K884285 · FMT
Gempco, Inc.
General Hospital · 71d