Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
145993–146016 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 1986
CALCIUM LIQUID STABLE REAGENT SET
K855041 · CIC
Medical Analysis Systems, Inc.
Chemistry · 36d
Cleared Jan 22, 1986
EMDS TOTAL CK TEST PACK-#67670/95
K855056 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Jan 22, 1986
TELEMETRY WAND MODEL
K855171 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 27d
Cleared Jan 22, 1986
GLUCOSE REAGENT SET
K855185 · CGE
Technostics Intl.
Chemistry · 27d
Cleared Jan 22, 1986
CLEANING REAGENT KIT PRODUCT NO 88194
K855196 · JJE
Hi Chem, Inc.
Chemistry · 27d
Cleared Jan 22, 1986
DETERMINATION OF GENTAMICIN
K860045 · LCD
Clinical Data, Inc.
Toxicology · 16d
Cleared Jan 22, 1986
DETERMINATION OF PHENOBARBITAL
K860046 · DLZ
Clinical Data, Inc.
Toxicology · 16d
Cleared Jan 22, 1986
DETERMINATION OF CARBAMAZEPINE
K860047 · KLT
Clinical Data, Inc.
Toxicology · 16d
Cleared Jan 22, 1986
DETERMINATION OF PHENYTOIN (DIPHENYLHYDANTOIN)
K860048 · DIP
Clinical Data, Inc.
Toxicology · 16d
Cleared Jan 22, 1986
DETERMINATION OF QUINIDINE
K860049 · LBZ
Clinical Data, Inc.
Toxicology · 16d
Cleared Jan 21, 1986
ROKONICS SENTRY MODEL 8500
K851819 · BZQ
Rokonics, Inc.
Anesthesiology · 270d
Cleared Jan 21, 1986
HSV2 - IGG ELISA-KIT
K852781 · GQO
Clinical Sciences, Inc.
Microbiology · 204d
Cleared Jan 21, 1986
HSVI - IGG ELISA-KIT
K852782 · GQO
Clinical Sciences, Inc.
Microbiology · 204d
Cleared Jan 21, 1986
MYO-ACTUATOR
K852963 · HCC
Verimed Holdings, Inc.
Neurology · 193d
Cleared Jan 21, 1986
TECHNICON H*1 SYSTEM SUB-CLASSIFICATION LUC CAT.
K852988 · GKZ
Technicon Instruments Corp.
Hematology · 190d
Cleared Jan 21, 1986
CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIO
K853090 · EMA
Psp Dental Co., Ltd.
Dental · 182d
Cleared Jan 21, 1986
CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE
K853091 · EMA
Psp Dental Co., Ltd.
Dental · 182d
Cleared Jan 21, 1986
EMERGENT TECHNOLOGY VENTILATORY EFFORT MONITOR VEM
K853252 · BZQ
Emergent Technology Corp.
Anesthesiology · 172d
Cleared Jan 21, 1986
TROLL-BITE
K853451 · EGZ
Trollplast, Inc.
Dental · 158d
Cleared Jan 21, 1986
OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS
K853585 · FET
Olympus Corp.
Gastroenterology & Urology · 148d
Cleared Jan 21, 1986
LINK DYNAMIC STAPLE
K853704 · JDR
Link America, Inc.
Orthopedic · 139d
Cleared Jan 21, 1986
PASCO RESISTANT 5 PANEL
K853862 · JWY
Pasco Laboratories, Inc.
Microbiology · 126d
Cleared Jan 21, 1986
ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS
K854129 · LIQ
Orion Diagnostica, Inc.
Microbiology · 104d
Cleared Jan 21, 1986
ESCORT ECG MONITOR SIEMENS SIRECUST 466
K854234 · DPS
Medical Data Electronics
Cardiovascular · 92d