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
158305–158328 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 07, 1982
DERM-A-TEC SKIN BARRIER FILM
K822713
Professional Medical Products, Inc.
General & Plastic Surgery · 91d
Cleared Dec 07, 1982
ELECTROSURGICAL UNIT
K823083 · GEI
Kelleher Corp.
General & Plastic Surgery · 49d
Cleared Dec 07, 1982
NEUROTRAC
K823116 · GWQ
Interspec, Inc.
Neurology · 47d
Cleared Dec 07, 1982
ELECTROENCEPHALOGRAPH
K823140 · GWQ
Nihon Kohden America, Inc.
Neurology · 36d
Cleared Dec 07, 1982
YSI #2600 MULTI-CHANNEL DUAL-DISPLAY
K823231 · CCL
Yellow Springs Instrument Co., Inc.
Anesthesiology · 39d
Cleared Dec 07, 1982
YSI #2650 SINGLE-DISPLAY OXYGEN & TEMP
K823232 · CCL
Yellow Springs Instrument Co., Inc.
Anesthesiology · 39d
Cleared Dec 07, 1982
UNI-TIP COLOSTOMY IRRIGATION CONE
K823274 · EXD
Howmedica Corp.
Gastroenterology & Urology · 34d
Cleared Dec 07, 1982
PORTABLE SHOWER BATH
K823327 · ILM
Wall Manufacturer, Inc.
Physical Medicine · 29d
Cleared Dec 07, 1982
NEPHROSS, ANDANTE H.F.
K823375 · KOC
Organon Teknika Corp.
Gastroenterology & Urology · 25d
Cleared Dec 07, 1982
BE#1000-INSTANT ON/OFF O2 VALVE
K823408 · BTM
Instrumentation Industries, Inc.
Anesthesiology · 22d
Cleared Dec 03, 1982
IRRIGATION SET
K822560 · NBH
Utah Medical Products, Inc.
Orthopedic · 101d
Cleared Dec 03, 1982
ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K
K822682 · DHN
Amico Lab, Inc.
Microbiology · 91d
Cleared Dec 03, 1982
SIGMA REAGENT SYSTEM NO. 885
K822733 · JBE
Sigma Chemical Co.
Hematology · 86d
Cleared Dec 03, 1982
MYCOTRIUM-GU
K822736 · JSI
Hana Biologics, Inc.
Microbiology · 85d
Cleared Dec 03, 1982
MYCOTRIUM-RS
K822737 · JSI
Hana Biologics, Inc.
Microbiology · 85d
Cleared Dec 03, 1982
BLOOD GAS EXPER. SYSTEM 8700
K822778 · JQP
Exper Corp., Inc.
Chemistry · 80d
Cleared Dec 03, 1982
ANTIBODY TO MUMPS VIRUS IFA TEST
K822826 · GRA
Electro-Nucleonics Laboratories, Inc.
Microbiology · 73d
Cleared Dec 03, 1982
GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY
K822867 · LCP
Isolab, Inc.
Chemistry · 67d
Cleared Dec 03, 1982
1424 TUMISTORE
K822914
Life-Tech Intl., Inc.
Gastroenterology & Urology · 63d
Cleared Dec 03, 1982
EBV-M KIT
K822985 · JRY
Litton Bionetics
Microbiology · 52d
Cleared Dec 03, 1982
METAL KNEE & HIP PROSTHESIS
K823051 · KWL
Zimmer, Inc.
Orthopedic · 46d
Cleared Dec 03, 1982
KINETIC MOTION BED
K823095 · IKZ
Motion Manufacturers, Inc.
Physical Medicine · 44d
Cleared Dec 03, 1982
AGAR P
K823102 · JSJ
Dms Laboratories
Microbiology · 44d
Cleared Dec 03, 1982
NATURALYTE BICARBONATE DIALYSATE 4400
K823115 · KRO
Erika, Inc.
Orthopedic · 43d