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
150289–150312 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 07, 1984
TOSHIBA DIGITAL CLINICAL THERMOMETER
K844124 · FLL
Toshiba Medical Systems
General Hospital · 45d
Cleared Dec 07, 1984
FLEXIBLE STAINLESS STEEL STYLET FOR ENTERNAL FEEDI
K844174 · KNT
Exco, Inc.
Gastroenterology & Urology · 43d
Cleared Dec 06, 1984
SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 8
K843129 · JOP
Advanced Technology Laboratories, Inc.
Cardiovascular · 119d
Cleared Dec 06, 1984
SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 4
K843130 · JOP
Advanced Technology Laboratories, Inc.
Cardiovascular · 119d
Cleared Dec 06, 1984
KETAC-SILVER
K843566 · EMA
Espe GmbH (Us)
Dental · 87d
Cleared Dec 06, 1984
CADD-1 5100 AMBULATORY INFUSION PUMP
K843772 · FRN
Deltec Systems, Inc.
General Hospital · 72d
Cleared Dec 06, 1984
CADD-PAC 5200 AMBULATORY INFUSION PUMP
K843773 · FRN
Deltec Systems, Inc.
General Hospital · 72d
Cleared Dec 06, 1984
HEPARIN INFUSIN PUMP
K843878 · FRN
Armament Systems, Inc.
General Hospital · 65d
Cleared Dec 06, 1984
FOCUSCOPE UNIVERSAL SYSTEM
K843900 · GDB
Medical Diagnostics, Ca.
Gastroenterology & Urology · 64d
Cleared Dec 06, 1984
FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY
K844105
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 44d
Cleared Dec 06, 1984
ENTAMOEBA HISTOLYTICA HK-9 ANTIGEN (AXENIC)
K844141 · KHW
Lmd Laboratories
Microbiology · 44d
Cleared Dec 05, 1984
COULTER COUNTER MODEL M4
K843303 · GKL
Coulter Electronics, Inc.
Hematology · 104d
Cleared Dec 05, 1984
COLOSCREEN SELF-TEST
K843352 · KHE
Helena Laboratories
Hematology · 100d
Cleared Dec 05, 1984
PHARMA-PLAST RECTAL TIP
K843477 · FCF
Zimmar Consulting , Ltd.
Gastroenterology & Urology · 90d
Cleared Dec 05, 1984
PHARMA-PLAST URIDROP-URIDOME
K843478 · KNX
Zimmar Consulting , Ltd.
Gastroenterology & Urology · 90d
Cleared Dec 05, 1984
INTRAVENOUS START KIT
K843813
Pro-Lab, Inc.
General & Plastic Surgery · 68d
Cleared Dec 05, 1984
PERCUTANEOUS NEPHROSTOMY TROCAR SYS
K844090 · LJE
American Edwards Laboratories
Gastroenterology & Urology · 44d
Cleared Dec 05, 1984
BIOSEARCH GLASER PEG PERCUTANEOUS ENDOSCOPIC GASTR
K844222 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 34d
Cleared Dec 05, 1984
OPHTHALMIC STAND
K844363 · HMF
Luneau Laboratories
Ophthalmic · 22d
Cleared Dec 05, 1984
PMS DRAPE PACK
K844465 · KKX
Professional Medical Services
General Hospital · 16d
Cleared Dec 05, 1984
QUANTUM 412
K844570 · HPT
Keta Corp.
Ophthalmic · 12d
Cleared Dec 04, 1984
ARM-A-FLOW INTRAVENOUS FLOW REGULATOR
K842209 · LDR
Armour Pharmaceutical Co.
General Hospital · 183d
Cleared Dec 04, 1984
DRESSING CHANGE TRAY STERILE 5002
K842404
Pro-Lab, Inc.
General & Plastic Surgery · 168d
Cleared Dec 04, 1984
SHAVE PREP KITS
K842989 · KME
Biological & Environmental Control...
General Hospital · 127d