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
157705–157728 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 07, 1983
SINGLE ACCESS DEVICE (SSAD)
K823715 · KOC
Samaritan Hospital
Gastroenterology & Urology · 59d
Cleared Feb 07, 1983
SCEPTOR GRAM-POSITIVE PANEL, MIC/10 TEMP
K823718 · JTO
Bd Becton Dickinson Vacutainer...
Microbiology · 59d
Cleared Feb 07, 1983
ET-3 EMERGENCY TRANSPORT VENTILATOR
K823861 · CBK
Bio-Med Devices, Inc.
Anesthesiology · 47d
Cleared Feb 07, 1983
GLUCOSE-6-PHOSPHATE DEHYDROGENASE
K823900 · KQE
Alladin Diagnostic, Inc.
Toxicology · 39d
Cleared Feb 07, 1983
MICRO JOIN, CROWN & BRIDGE ADHESIVE
K823935 · EMA
Sci-Pharm, Inc.
Dental · 40d
Cleared Feb 07, 1983
ACETAMIDE AGAR
K830020 · JSH
Gibco Laboratories Life Technologies,...
Microbiology · 34d
Cleared Feb 07, 1983
DISPOSABLE CYSTOTOME
K830040 · HNY
Contemporary Surgical Systems, Inc.
Ophthalmic · 31d
Cleared Feb 07, 1983
MODEL HI-FLO2 OXYGEN RICH AIR SUPPLY
K830046 · CAW
Greene & Kellogg, Inc.
Anesthesiology · 28d
Cleared Feb 07, 1983
SHUR GEL
K830083 · ELW
Columbus Dental Mfg. Co.
Dental · 27d
Cleared Feb 07, 1983
DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR
K830090 · JXL
Hudson Oxygen Therapy Sales Co.
Neurology · 27d
Cleared Feb 07, 1983
CONTINUOUS ANATOMICAL PASSIVE EXERCISER
K830122 · BXB
Zimmer, Inc.
Physical Medicine · 27d
Cleared Feb 07, 1983
PARAMOUNT THYROXINE ASSAY
K830136 · KLI
Syva Co.
Chemistry · 25d
Cleared Feb 07, 1983
CALIBRATOR A
K830137 · JIS
Hi Chem, Inc.
Chemistry · 25d
Cleared Feb 07, 1983
TANDEM E GCG VISUAL END POINT INNUMOENZ
K830138 · JHI
Hybritech, Inc.
Chemistry · 25d
Cleared Feb 07, 1983
SIGMA 300 GAS CHROMATROGRAPH
K830147 · KZQ
The Perkin-Elmer Corp.
Toxicology · 21d
Cleared Feb 07, 1983
OREXAS POTENTEST
K830158 · LIL
Orexas Medical Corp.
Gastroenterology & Urology · 20d
Cleared Feb 07, 1983
DORC ADJUSTABLE IMAGE CONTACTS
K830169 · HKS
Jedmed Instrument Co.
Ophthalmic · 20d
Cleared Feb 07, 1983
RIASSIST RAST DATA REDUCTION/QUALITY
K830170 · DHB
Ventrex Laboratories, Inc.
Chemistry · 20d
Cleared Feb 07, 1983
HARVARD APPARATUS FAMILY OF FLUID INFUS
K830177 · FRN
C.R. Bard, Inc.
General Hospital · 20d
Cleared Feb 07, 1983
MINILOOP DISPOS. IV CONNECTORS ADAPT.
K830178 · FPA
Medex, Inc.
General Hospital · 20d
Cleared Feb 07, 1983
PEDIATRIC EXTEN. SET FOR SECOND-DRUG
K830198 · FMG
Travenol Laboratories, S.A.
General Hospital · 18d
Cleared Feb 03, 1983
LARGE TERRYCLOTH BIB
K823598
Fred Sammons, Inc.
Physical Medicine · 59d
Cleared Feb 03, 1983
NON-SLIP VINYL BATH MAT
K823631
Fred Sammons, Inc.
Physical Medicine · 59d
Cleared Feb 03, 1983
INFLATABLE PILLOW
K823643
Fred Sammons, Inc.
Physical Medicine · 59d