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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
108721–108744 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 20, 1994
UNKNOWN
K934774 · LSE
Granbio, Inc.
Microbiology · 197d
Cleared Apr 20, 1994
KACEY DISPOSABLE GLOVE LINER
K935158 · LYU
K & C Medical, Inc.
General Hospital · 174d
Cleared Apr 20, 1994
HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)
K935828 · LLL
Hemagen Diagnostics, Inc.
Immunology · 134d
Cleared Apr 20, 1994
LCI-100 AND LCI-200 WELCH ALLYN ILLUMINATION AND IMAGING SYSTEM
K940270 · GCT
Welch Allyn, Inc.
Gastroenterology & Urology · 89d
Cleared Apr 20, 1994
ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL
K940272 · JJX
Analytical Control Systems, Inc.
Chemistry · 98d
Cleared Apr 20, 1994
HELENA THROMBOPLASTIN-MI REAGENT
K940310 · GJS
Helena Laboratories
Hematology · 86d
Cleared Apr 20, 1994
ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT
K940510 · LKP
Helix Diagnostics, Inc.
Immunology · 75d
Cleared Apr 20, 1994
SYNERMED TOTAL BILIRUBIN REAGENT KIT
K940570 · CIG
Synermed, Inc.
Chemistry · 71d
Cleared Apr 20, 1994
TENDERBREDE(R) PACKING AND DEBRIDEMENT SPONGE
K940574 · EFQ
Kendall Healthcare Products Co....
General & Plastic Surgery · 71d
Cleared Apr 20, 1994
ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT
K940588 · LKO
Helix Diagnostics, Inc.
Immunology · 71d
Cleared Apr 20, 1994
APPENDIX EXTRACTOR 8385.50
K940900 · GCJ
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 55d
Cleared Apr 19, 1994
MARQUETTE EAGLE MONITOR
K920790 · DSI
Marquette Electronics, Inc.
Cardiovascular · 788d
Cleared Apr 19, 1994
BABYLOG 8000 INFANT VENTILATOR
K926292 · CBK
Drager, Inc.
Anesthesiology · 491d
Cleared Apr 19, 1994
SURE-FLO INSUFFLATION TUBING
K930696 · HIF
O.R. Resources, Inc.
Obstetrics & Gynecology · 433d
Cleared Apr 19, 1994
LINK CERAMIC HEADS 12/14 X 32MM
K931571 · LZO
Link America, Inc.
Orthopedic · 385d
Cleared Apr 19, 1994
INSEMI-CATH
K931630 · MFD
Cook Ob/Gyn
Obstetrics & Gynecology · 382d
Cleared Apr 19, 1994
C-SECTION, LABOR & DELIVERY TRAYS (PACKS)
K932216 · MLS
Associated Medical Products Co.
Obstetrics & Gynecology · 347d
Cleared Apr 19, 1994
BERICHROM ANTITHROMBIN III (A)
K933125 · JPE
Behring Diagnostics, Inc.
Hematology · 295d
Cleared Apr 19, 1994
INMAN ENDOSCOPIC BLUNT DISSECTOR
K933169 · GCJ
Inman Medical Corp.
General & Plastic Surgery · 294d
Cleared Apr 19, 1994
APOLLO(TM) HIP SYST-STRAIGHT STEM/ALL-POLY ACET COMP
K933203 · LZO
Intermedics Orthopedics
Orthopedic · 292d
Cleared Apr 19, 1994
D'AMICO\PEYMAN FLUTED ENDOPROBE
K933211 · GEX
Iriderm Div.
General & Plastic Surgery · 350d
Cleared Apr 19, 1994
GROUND/REFERENCE NEEDLE ELECTRODE
K933793 · GXZ
Cadwell Laboratories, Inc.
Neurology · 258d
Cleared Apr 19, 1994
COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER
K934266 · EXJ
Sierra Laboratories, Inc.
Gastroenterology & Urology · 231d
Cleared Apr 19, 1994
MULTIFIBREN U
K934326 · KQJ
Behring Diagnostics, Inc.
Hematology · 228d