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
152521–152544 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 1984
THERMODILUTION CATHETER
K840992 · KRB
Gould, Inc.
Cardiovascular · 77d
Cleared May 23, 1984
OXYHI CRYSTALLOID CARDIOPLEGIA SOLUT
K841031 · DTN
American Bentley
Cardiovascular · 72d
Cleared May 23, 1984
HUCKSTEPS STAPLES
K841125
Downs Surgical , Ltd.
Orthopedic · 69d
Cleared May 23, 1984
BEAR 33
K841279 · CBK
Bear Medical Systems, Inc.
Anesthesiology · 56d
Cleared May 23, 1984
REESE OSTEOTOMY GUIDE SYS
K841470 · HTH
Osteotomy Guide Co.
Orthopedic · 44d
Cleared May 23, 1984
ARTERIAL BLOOD SAMPLING KITS
K841486 · CBT
Concord Laboratories, Inc.
Anesthesiology · 43d
Cleared May 23, 1984
SIEMENS-ELEMA VENTILATOR 900C
K841529 · CBK
Siemens Elema AB
Anesthesiology · 40d
Cleared May 23, 1984
TRIPLE LUMEN INFUSION CATHETER/ACCESS
K841535
Gish Biomedical, Inc.
Cardiovascular · 86d
Cleared May 23, 1984
PATIENT TUBING HYTREL SIEMENS-ELEMA
K841657 · BZO
Siemens Elema AB
Anesthesiology · 30d
Cleared May 23, 1984
INNOFLUOR PHENOBARBITAL
K841707 · LGQ
Innotron Diagnostics
Toxicology · 30d
Cleared May 23, 1984
D.L. SCOPE BLADE & HANDLE
K841778 · CCW
North American Medical Products, Inc.
Anesthesiology · 23d
Cleared May 23, 1984
ALPHA PUSH KART
K841911 · INM
Alpha Unlimited, Inc.
Physical Medicine · 14d
Cleared May 23, 1984
ALPHA 4 X 4
K841912 · ITI
Alpha Unlimited, Inc.
Physical Medicine · 14d
Cleared May 23, 1984
ALPHA TRI-KART
K841919 · INI
Alpha Unlimited, Inc.
Physical Medicine · 13d
Cleared May 23, 1984
MAC-MULTI-ADJUSTABLE CHAIR
K841920 · IPL
Alpha Unlimited, Inc.
Physical Medicine · 13d
Cleared May 23, 1984
ALPHA PLUS 1
K841921 · ITI
Alpha Unlimited, Inc.
Physical Medicine · 13d
Cleared May 23, 1984
OASIS CLUB HYDROMASSAGE
K841954 · ILJ
Prexcor America, Inc.
Physical Medicine · 9d
Cleared May 23, 1984
EZY-RAMP
K841994
Ezy-Ramp Co.
Physical Medicine · 8d
Cleared May 23, 1984
OHIO WASTE GAS SCAVENGING INTERFACE
K842003 · CBN
Ohio Medical Products
Anesthesiology · 7d
Cleared May 22, 1984
DILATION BALLOON CATHETER
K834413 · FGE
Hobbs Medical, Inc.
Gastroenterology & Urology · 159d
Cleared May 22, 1984
I/A PROBE LINES
K834577
Frigitronics of Connecticut, Inc.
General & Plastic Surgery · 145d
Cleared May 22, 1984
EXTRACTABLE NUCLEAR ANTIGEN ASSAY
K840221 · LLL
Zeus Scientific, Inc.
Microbiology · 124d
Cleared May 22, 1984
DISPOSABLE SCLERAL GLOBE PLUG
K840693 · LXP
Innovative Surgical Products, Inc.
Ophthalmic · 96d
Cleared May 22, 1984
PHACOEMULSIFICATION KITS
K840695 · HQC
Innovative Surgical Products, Inc.
Ophthalmic · 96d