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
169753–169776 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 1979
ANALYZER, IMPACT 100
K790073 · JJI
Gilford Instrument Laboratories, Inc.
Chemistry · 42d
Cleared Feb 22, 1979
BK-5371 GAD-19-BOUT PERSONAL MOBIL AID
K790173 · IKW
Fred Sammons, Inc.
Physical Medicine · 27d
Cleared Feb 22, 1979
SEMI-RECLINING BATH CHARI & BELT
K790175 · ILS
Fred Sammons, Inc.
Physical Medicine · 27d
Cleared Feb 22, 1979
DRAPE PACKS, SURGICAL GOWNS
K790234 · KKX
Convertors
General Hospital · 20d
Cleared Feb 22, 1979
EDGE PROTECTOR, BARRIER
K790306 · KGW
Surgikos, Inc.
General & Plastic Surgery · 9d
Cleared Feb 22, 1979
FLEXIBLE REAMER, GUIDE WIRE SYSTEM
K790307 · HTO
3M Company
Orthopedic · 9d
Cleared Feb 22, 1979
NEPHROSS 11F100
K790352
Redy Laboratories
Gastroenterology & Urology
Cleared Feb 21, 1979
MARNE M.T.P.J. ORTHOPEDIC IMPLANT
K781380 · KYJ
Farah , Ltd.
Orthopedic · 194d
Cleared Feb 21, 1979
DIALYZER, MAGNIFLO 100 PARALLEL PLATE
K781966 · FJG
Erika, Inc.
Gastroenterology & Urology · 89d
Cleared Feb 21, 1979
DETECTOR PAD
K782093 · KPN
Halperin Institute, Ltd. The
Gastroenterology & Urology · 69d
Cleared Feb 21, 1979
ZYLOX
K782139 · ELW
Premier Dental Products Co.
Dental · 56d
Cleared Feb 21, 1979
DELTA FLOW
K782167 · FMG
Medex, Inc.
General Hospital · 54d
Cleared Feb 21, 1979
ALKALINE PHOSPHATASE
K790065 · CJE
Macomb Chemical Co.
Chemistry · 37d
Cleared Feb 21, 1979
FILM-X 90
K790121 · IXW
Automatic Film Processor Corp.
Radiology · 29d
Cleared Feb 21, 1979
TECNOTOMO
K790132 · IZF
Teknomed, Inc.
Radiology · 29d
Cleared Feb 21, 1979
RADIOTHERAPY TREATMENT
K790134 · JAK
General Electric Co.
Radiology · 29d
Cleared Feb 21, 1979
LIMB SHEET WITH FABRIC 450
K790225 · KKX
Surgikos, Inc.
General Hospital · 19d
Cleared Feb 21, 1979
DENTRIFICATION LACTOSE AGAR
K790230 · JSE
Los Angeles Biological Products
Microbiology · 19d
Cleared Feb 21, 1979
DECARBOXYLASE, BUFFERED LYSINE
K790231 · JSF
Los Angeles Biological Products
Microbiology · 19d
Cleared Feb 21, 1979
AGAR, MOTILITY-NITRATE
K790232 · JSE
Los Angeles Biological Products
Microbiology · 19d
Cleared Feb 21, 1979
GUN, EXETER CEMENT
K790275 · KIH
Howmedica Corp.
Orthopedic · 12d
Cleared Feb 21, 1979
FOREARM-CANE
K790299 · IPS
Guardian Products Co., Inc.
Physical Medicine · 9d
Cleared Feb 21, 1979
ENDOTRACHEAL TUBE W/HOLDER & CONNECTOR
K790312 · BTR
Respiratory Support Products, Inc.
Anesthesiology · 8d
Cleared Feb 16, 1979
ANTISERA, RHODAMINE CONJUGATED FRAGMENT
K781951 · DCE
Kallestad Laboratories, Inc.
Immunology · 87d