FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
135601–135624 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 21, 1988
TEAMMATE(TM)
K880569 · FRN
Infusion Systems Corp.
General Hospital · 71d
Cleared Apr 21, 1988
MINIMED MODEL 404-SP EXTERNAL INFUSION PUMP
K880623 · FRN
Medtronic Minimed
General Hospital · 65d
Cleared Apr 21, 1988
2K-QDA MOTION/GAIT ANALYSIS SYSTEM
K880631 · LXJ
Human Performance Technologies, Inc.
Physical Medicine · 65d
Cleared Apr 21, 1988
HBF DILUENT
K880653 · KQI
Helena Laboratories
Hematology · 64d
Cleared Apr 21, 1988
DIASONICS QT ENDORECTAL 7.5 MHZ PROBE
K880714 · IYO
Diasonics, Inc.
Radiology · 59d
Cleared Apr 21, 1988
PHARMACIA B2-MICRO RIA
K880719 · JZG
Pharmacia, Inc.
Microbiology · 58d
Cleared Apr 21, 1988
BLOOD COLLECTING NEEDLE AND HOLDERS
K880892 · FMI
Abco Dealers, Inc.
General Hospital · 50d
Cleared Apr 21, 1988
NOVA GEL (TM) SCL-70
K880897 · LLL
Inova Diagnostics, Inc.
Immunology · 50d
Cleared Apr 21, 1988
RICH-MAR G1000 EMS
K880948 · IPF
Rich-Mar Corp.
Physical Medicine · 45d
Cleared Apr 21, 1988
AXILLARY BLOCK NEEDLE
K880970 · CAZ
Bd Becton Dickinson Vacutainer...
Anesthesiology · 44d
Cleared Apr 21, 1988
CO2 RIGID LASER ENDOSCOPE PROBE SERIES 792/LAPARO
K881010 · HET
Sharplan Lasers, Inc.
Obstetrics & Gynecology · 42d
Cleared Apr 21, 1988
CENTRY 2 ULTRAFILTRATION CONTROL KIT, #018762-002
K881062 · FJB
Cobe Laboratories, Inc.
Gastroenterology & Urology · 38d
Cleared Apr 21, 1988
MODIFIED NEO-I TEMPERATURE, CONDUCTIVITY METER
K881098 · FIZ
Automata, Inc.
Gastroenterology & Urology · 37d
Cleared Apr 21, 1988
ACID FAST BACILLI HISTOLOGY CONTROL SLIDES
K881106 · LJG
Sigma Diagnostics, Inc.
Microbiology · 37d