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
136201–136224 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 21, 1988
SPIROCHETES HISTOLOGY CONTROL SLIDES
K881109 · LJG
Sigma Diagnostics, Inc.
Microbiology · 37d
Cleared Apr 21, 1988
FUNGI HISTOLOGY CONTROL SLIDES
K881112 · LJG
Sigma Diagnostics, Inc.
Microbiology · 37d
Cleared Apr 21, 1988
QM300 CALIBRATOR D PACK
K881127 · DCF
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 36d
Cleared Apr 21, 1988
CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO.
K881138 · JMG
Baxter Healthcare Corp
Immunology · 36d
Cleared Apr 21, 1988
CELL-DYN RAPID-LYSE AND HEMOGLOBLIN
K881242 · GJZ
Abbott Diagnostics
Hematology · 36d
Cleared Apr 21, 1988
ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SW
K881253 · ELC
Dentalez Group
Dental · 29d
Cleared Apr 21, 1988
NON CORING INFUSION SET
K881256 · LJT
Taris Corp.
General Hospital · 29d
Cleared Apr 21, 1988
ASSIST-A-LIFT
K881298 · INO
Action Engineering, Inc.
Physical Medicine · 24d
Cleared Apr 21, 1988
ORTHODONTIC NITINOL SPRINGS
K881331 · EJW
Flexmedics
Dental · 23d
Cleared Apr 21, 1988
OLYMPIA ALLOY
K881333 · EJJ
J.F. Jelenko & Co., Inc.
Dental · 23d