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
134497–134520 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 02, 1988
WHEELCHAIR BCW 6000
K883034 · IOR
O'Tec Corp.
Physical Medicine · 14d
Cleared Aug 02, 1988
COMFORT CATH MALE EXTERNAL CATHETER
K883057 · EYT
Sierra Laboratories, Inc.
Gastroenterology & Urology · 14d
Cleared Aug 02, 1988
VPI NON-ADHESIVE CONDOM CATHETER
K883119 · EYT
Cook Urological, Inc.
Gastroenterology & Urology · 8d
Cleared Aug 01, 1988
ACUTRON
K880042 · GZJ
Davis Assoc.
Neurology · 209d
Cleared Aug 01, 1988
MODEL 130YZ CO2-YAG SURGICAL LASER SYSTEM
K880816 · GEX
Niic U.S.A., Inc.
General & Plastic Surgery · 166d
Cleared Aug 01, 1988
CAPTIA TOXO-G
K880918 · LGD
Mercia Diagnostics , Ltd.
Microbiology · 150d
Cleared Aug 01, 1988
THE LAITINEN STEREOTACTIC SYSTEM
K881131 · HAW
Sandstrom Trade & Technology, Inc.
Neurology · 138d
Cleared Aug 01, 1988
ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT
K881932 · GQH
Ortho Diagnostic Systems, Inc.
Microbiology · 83d
Cleared Aug 01, 1988
BIO-RAD HEMOGLOBIN DETECTOR
K882051 · LCP
Bio-Rad
Hematology · 77d
Cleared Aug 01, 1988
DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY
K882222 · LCP
Bio-Rad
Hematology · 67d
Cleared Aug 01, 1988
AEROSOL DELIVERY HOOD
K882396 · BYL
Viratek, Inc.
Anesthesiology · 52d
Cleared Aug 01, 1988
VAPORIZER, ANESTHESIA, NON-HEATED
K882500 · CAD
Anesthetic Vaporizer Services
Anesthesiology · 45d
Cleared Aug 01, 1988
ACE CANCELLOUS BONE SCREW
K882831 · HWC
Buckman Co., Inc.
Orthopedic · 24d
Cleared Aug 01, 1988
DULBECCO'S MODIFIED EAGLE'S MEDIUM, NO. 200-2183
K882837 · KIT
J R Scientific
Pathology · 24d
Cleared Aug 01, 1988
DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 210-3501
K882846 · KIT
J R Scientific
Pathology · 21d
Cleared Aug 01, 1988
MINIMUM ESSENTIAL MEDIUM EAGLE NO. 210-3515
K882847 · KIT
J R Scientific
Pathology · 21d
Cleared Aug 01, 1988
RPMI-1640 MEDIUM, CATALOG NO. 210-3521
K882848 · KIT
J R Scientific
Pathology · 21d
Cleared Aug 01, 1988
DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 210-3500
K882849 · KIT
J R Scientific
Pathology · 21d
Cleared Aug 01, 1988
NUTRIENT MIXTURE F-10 (HAM) NO. 210-3550
K882850 · KIT
J R Scientific
Pathology · 21d
Cleared Aug 01, 1988
RPMI-1640 MEDIUM, CATALOG NO. 210-3523
K882851 · KIT
J R Scientific
Pathology · 21d
Cleared Aug 01, 1988
RPMI-1640 MEDIUM, CATALOG NO. 210-3520
K882853 · KIT
J R Scientific
Pathology · 21d
Cleared Aug 01, 1988
MEDIUM 199, CATALOG NO. 210-3536
K882854 · KIT
J R Scientific
Pathology · 21d
Cleared Aug 01, 1988
MINIMUM ESSENTIAL MEDIUM EAGLE NO. 210-3510
K882860 · KIT
J R Scientific
Pathology · 21d
Cleared Aug 01, 1988
MINIMUM ESSENTIAL MEDIUM EAGLE NO. 210-3514
K882861 · KIT
J R Scientific
Pathology · 21d