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
136177–136200 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 25, 1988
YANKAUER SUCTION INSTRU./LAYTEX GLOVES/SUCT. CATH.
K881429 · CAZ
Medical Repackers Co.
Anesthesiology · 27d
Cleared Apr 22, 1988
S-ROM SUPERCUP ACETABULAR CUP
K870088 · LWJ
Joint Medical Products Corp.
Orthopedic · 469d
Cleared Apr 22, 1988
EUB-305 DIAGNOSTIC ULTRASOUND DEVICE
K870878 · DXK
Hitachi Medical Corp. of America
Cardiovascular · 415d
Cleared Apr 22, 1988
REI-38 RADIOGRAPHIC TABLE
K873702 · IXQ
Radiological Engineering, Inc.
Radiology · 221d
Cleared Apr 22, 1988
ELECTRIC MOBILITY'S SPARKY
K874739 · ITI
Electric Mobility Corp.
Physical Medicine · 156d
Cleared Apr 22, 1988
PERIPHERAL DILATATION CATHETER
K880298 · LIT
Medi-Tech, Inc.
Cardiovascular · 88d
Cleared Apr 22, 1988
ANGIO DRAPE PACK ACP-010FM
K880310 · DXT
Arrow Intl., Inc.
Cardiovascular · 88d
Cleared Apr 22, 1988
MIC (SPECIFIC LINE) REPLACEMENT KIT
K880768 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 56d
Cleared Apr 22, 1988
A2J MZ 44 B TYPE
K880981 · IWE
A2j, Inc.
Radiology · 45d
Cleared Apr 22, 1988
LEUKOPOR(TM) SURGICAL TAPE
K881509 · KGX
Beiersdorf, Inc.
General & Plastic Surgery · 11d
Cleared Apr 21, 1988
VEOLAR VENTILATOR
K871792 · CBK
Hamilton Medical, Inc.
Anesthesiology · 350d
Cleared Apr 21, 1988
ANKLE REFLEX TREATMENT UNIT (ARTU)
K873658 · BXB
Universal Gym Equipment, Inc.
Physical Medicine · 224d
Cleared Apr 21, 1988
MUSCULOSKELETAL EVALUATION REHABILITATION/CONDITIO
K873659 · IKK
Universal Gym Equipment, Inc.
Physical Medicine · 224d
Cleared Apr 21, 1988
TDX (R) AMPHETAMINE CLASS
K874770 · DKZ
Abbott Laboratories
Toxicology · 154d
Cleared Apr 21, 1988
RT-200 COMPUTER INTERFACE
K875075 · BXX
Timeter Instrument Corp.
Anesthesiology · 134d
Cleared Apr 21, 1988
GOLDENROD ALLERGEN DISC
K875163 · DHB
Incstar Corp.
Immunology · 127d
Cleared Apr 21, 1988
ALLEIA (TM) ALLERGEN SPECIFIC IGE SYSTEM
K875244 · DHB
Diagnostic Products Corp.
Immunology · 121d
Cleared Apr 21, 1988
SERODOT TOXOPLASMA IGG TEST KIT
K875363 · LGD
Disease Detection International, Inc.
Microbiology · 112d
Cleared Apr 21, 1988
FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527
K880038 · KHG
Sigma Diagnostics, Inc.
Hematology · 107d
Cleared Apr 21, 1988
DPC'S ALLERGEN-SPECIFIC IGE SYSTEM
K880160 · DHB
Diagnostic Products Corp.
Immunology · 99d
Cleared Apr 21, 1988
INCSTAR'S DANDELION ALLERGEN DISC
K880187 · DHB
Incstar Corp.
Immunology · 97d
Cleared Apr 21, 1988
EXPANDOVER ELASTIC BANDAGE
K880207 · KGX
Expandover C/O Hale and Dorr
General & Plastic Surgery · 97d
Cleared Apr 21, 1988
MESQUITE ALLERGEN DISC
K880415 · DHB
Incstar Corp.
Immunology · 80d
Cleared Apr 21, 1988
WHITE ASH ALLERGEN DISC
K880567 · DHB
Incstar Corp.
Immunology · 71d