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
144433–144456 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 1986
KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS
K861022 · JTR
Micro-Bio-Logics
Microbiology · 17d
Cleared Apr 04, 1986
SUPERLITE PENLIGHT
K861028
Keta Corp.
Ophthalmic · 17d
Cleared Apr 04, 1986
AR-1600 AUTOMATIC REFRACTOR
K861062 · HKO
Nidek, Inc.
Ophthalmic · 15d
Cleared Apr 04, 1986
NIDEK KM-800 AUTO KERATOMETER
K861063 · HLQ
Nidek, Inc.
Ophthalmic · 15d
Cleared Apr 04, 1986
AR-1000 AUTOMATIC REFRACTOR
K861066 · HKO
Nidek, Inc.
Ophthalmic · 15d
Cleared Apr 04, 1986
PB 254 IR - SPECTROMETER
K861213 · CCK
Datex Division Instrumentarium Corp.
Anesthesiology · 4d
Cleared Apr 03, 1986
PSP C & B TEMP
K853092 · EBG
Psp Dental Co., Ltd.
Dental · 254d
Cleared Apr 03, 1986
AUDIANT BONE CONDUCTOR OR A.B.C.
K855059 · LXB
Xomed, Inc.
Ear, Nose, Throat · 106d
Cleared Apr 03, 1986
SGOT (AST) REAGENT SET
K860216 · CIQ
Sterling Diagnostics, Inc.
Chemistry · 71d
Cleared Apr 03, 1986
MARDIS DANGLER URETERAL STENT SET
K860267 · FAD
Van-Tec, Inc.
Gastroenterology & Urology · 66d
Cleared Apr 03, 1986
VAN-TEC DEFLECTING GRASPING FORCEPS
K860268 · FFL
Van-Tec, Inc.
Gastroenterology & Urology · 66d
Cleared Apr 03, 1986
TI-FIT ACETABULAR COMPONENT
K860275 · LZO
Richards Medical Co., Inc.
Orthopedic · 66d
Cleared Apr 03, 1986
A-GENT LIQUID TOTAL BILIRUBIN
K860424 · CIG
Abbott Laboratories
Chemistry · 58d
Cleared Apr 03, 1986
A-GENT LIQUID CALCIUM
K860425 · CIC
Abbott Laboratories
Chemistry · 58d
Cleared Apr 03, 1986
A-GENT LIQUID TOTAL PROTEIN
K860426 · CEK
Abbott Laboratories
Chemistry · 58d
Cleared Apr 03, 1986
URIC ACID REAGNET SET (TRINDER)
K860477 · KNK
Sterling Diagnostics, Inc.
Chemistry · 55d
Cleared Apr 03, 1986
SGPT (ALT) REAGENT SET (COLORIMETRIC)
K860485 · CKD
Sterling Diagnostics, Inc.
Chemistry · 52d
Cleared Apr 03, 1986
EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93
K860641 · DLI
Em Diagnostic Systems, Inc.
Chemistry · 42d
Cleared Apr 03, 1986
ASPARTATE AMINOTRANSFERASE (AST/SGOT) REAGENT SET
K860667 · CIT
Sterling Diagnostics, Inc.
Chemistry · 38d
Cleared Apr 03, 1986
DAHLBERG MODEL EF BEHIND-THE-EAR HEARING AID
K860671 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 38d
Cleared Apr 03, 1986
ANALYTE IRON/TECHNICON CHEM 1 SYSTEM
K860799 · JIY
Technicon Instruments Corp.
Chemistry · 30d
Cleared Apr 03, 1986
TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICIN
K860868 · LCD
Technicon Instruments Corp.
Chemistry · 27d
Cleared Apr 03, 1986
EASY-TEST AMLASE (AMYL), #67521/93
K860918 · JFJ
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Apr 03, 1986
DAVIS LOOP STONE EXTRACTOR/URETERAL CATHETER
K860946 · FFL
Van-Tec, Inc.
Gastroenterology & Urology · 22d