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
148345–148368 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 1985
TDX TOTAL T3
K851676 · CDP
Abbott Laboratories
Chemistry · 27d
Cleared May 20, 1985
CREATINE LIQUID STABLE REAGENT SET
K851849 · CGX
Medical Analysis Systems, Inc.
Chemistry · 24d
Cleared May 20, 1985
MCDB 302 MEDIUM, M2021
K851862 · KIT
Sigma Cell Culture Reagents
Pathology · 24d
Cleared May 20, 1985
NCTC-135 MEDIUM N3262
K851863 · KIT
Sigma Cell Culture Reagents
Pathology · 24d
Cleared May 20, 1985
AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE
K851865 · CIT
Amresco, Inc.
Chemistry · 21d
Cleared May 20, 1985
TOTAL PROTEIN LIQUID STABLE REAGENT SET
K851877 · CEK
Medical Analysis Systems, Inc.
Chemistry · 21d
Cleared May 20, 1985
MULTI FUNCTION BLOOD GAS CONTROL
K851911 · JJS
Bionostics, Inc.
Chemistry · 19d
Cleared May 20, 1985
VERO GENCELLS
K851927 · KIR
Genus Diagnostics
Pathology · 18d
Cleared May 20, 1985
HEK GENCELLS
K851928 · KIR
Genus Diagnostics
Pathology · 18d
Cleared May 20, 1985
ORIGINAL ULTRAVIOLET SUNTANNING LAMP
K852053 · FTC
Mottek Intl. Corp.
General & Plastic Surgery · 11d
Cleared May 17, 1985
THERAPEUTIC LIMB MANIPULATOR
K844118 · BXB
Donald E. Redding
Physical Medicine · 206d
Cleared May 17, 1985
QUINTON INJECTION SEALING CAP
K844193 · FOZ
Quinton, Inc.
General Hospital · 199d
Cleared May 17, 1985
ALCIDE REN NEW-D
K844734 · FKQ
Alcide Corp.
Gastroenterology & Urology · 164d
Cleared May 17, 1985
CURAMED 402
K850573 · IMJ
Fluidotherapy Corp.
Physical Medicine · 93d
Cleared May 17, 1985
TEMP/SC 200T -SKIN CONDUCTANCE/SKIN TEMP BIOFEEDBA
K850642 · HCC
Thought Technology , Ltd.
Neurology · 87d
Cleared May 17, 1985
HR/BVP 100T HEART RATE MONITOR
K850643 · HCC
Thought Technology , Ltd.
Neurology · 87d
Cleared May 17, 1985
WSP CODE 4310 STRESSCATH
K850694 · FAP
Warne Surgical Products, Ltd.
Gastroenterology & Urology · 85d
Cleared May 17, 1985
WSP CODE 4300 DIOMASTER DIAGNOSTIC
K850696 · FAP
Warne Surgical Products, Ltd.
Gastroenterology & Urology · 85d
Cleared May 17, 1985
MEDIUM FREQU. ELEC. MUSCLE STIMULATOR
K850698 · IPF
Chattanooga Group, Inc.
Physical Medicine · 85d
Cleared May 17, 1985
STERILE CORMED MEDIPORT
K850967 · LJT
Cormed, Inc., Sub. C.R.Bard, Inc.
General Hospital · 70d
Cleared May 17, 1985
UTILIZATION OF ND:YAG LASER FOR TREATMENT RECTAL P
K851527 · GEX
Endo Lase, Inc.
General & Plastic Surgery · 31d
Cleared May 17, 1985
DISPOSABLE ISOLATION GOWN
K851823 · FYC
American Threshold Industries, Inc.
General Hospital · 21d
Cleared May 17, 1985
SKYTRON ELITE 3100 SURGICAL TABLE
K851829 · GDC
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 21d
Cleared May 17, 1985
SKYTRON ELITE 7000 MICRO-SURGERY TABLE
K851830 · GDC
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 21d