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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
110185–110208 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 03, 1994
MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION
K935506 · FMI
Kawasumi Laboratories Co., Ltd.
General Hospital · 79d
Cleared Feb 03, 1994
NASAL CANNULA
K935533 · CAT
Puritas Health Care, Inc.
Anesthesiology · 79d
Cleared Feb 03, 1994
NIL
K935687 · EAX
Dentalsafe Systems Pty., Ltd.
Dental · 66d
Cleared Feb 03, 1994
COLORED POWDER FREE PATIENT EXAMINATION GLOVES
K935699 · LYY
Glove India Private , Ltd.
General Hospital · 65d
Cleared Feb 03, 1994
CICA-CARE SILICONE GEL SHEET
K935803 · MDA
Smith & Nephew United, Inc.
General & Plastic Surgery · 63d
Cleared Feb 03, 1994
CIBA CORNING 248 PH/BLOOD GAS ANALYZER
K935830 · CHL
Ciba Corning Diagnostics Corp.
Chemistry · 58d
Cleared Feb 03, 1994
CHROMOPHARE
K935832 · KZF
Berchtold Holding GmbH
General Hospital · 58d
Cleared Feb 03, 1994
NEUROLOGICAL SPONGES
K935883 · GDY
Mcneil Healthcare, Inc.
General & Plastic Surgery · 56d
Cleared Feb 03, 1994
NON ADHERENT DRESSING AND NON ADHERENT DRAIN DRESSING
K935930 · EFQ
Mcneil Healthcare, Inc.
General & Plastic Surgery · 52d
Cleared Feb 03, 1994
PREPARE LOCK
K936094 · CBH
Prepare, Inc.
Anesthesiology · 43d
Cleared Feb 03, 1994
CLEARFIL LINER BOND 2
K936100 · KLE
Kuraray Intl. Corp.
Dental · 43d
Cleared Feb 03, 1994
RHESUS MONKEY KIDNEY CELLS
K936169 · KIR
Advanced Clinical Diagnostics
Pathology · 42d
Cleared Feb 03, 1994
TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY
K936171 · KIR
Advanced Clinical Diagnostics
Pathology · 42d
Cleared Feb 03, 1994
RHESUS MONKEY KIDNEY CELLS (LLC-MK2)
K936172 · KIR
Advanced Clinical Diagnostics
Pathology · 42d
Cleared Feb 03, 1994
NPAC
K936210 · KKX
National Healthcare Linen Service
General Hospital · 36d
Cleared Feb 02, 1994
MEDCOMP PERITONEAL DIALYSIS CATHETERS
K915490 · FJS
Medical Components, Inc.
Gastroenterology & Urology · 789d
Cleared Feb 02, 1994
SONASSAGE
K923238 · IRO
Conair Corp.
Physical Medicine · 580d
Cleared Feb 02, 1994
ARTHRITIC HEAT WRAP
K925820 · IRT
Conair Corp.
Physical Medicine · 442d
Cleared Feb 02, 1994
SIL-SLIP FLAT SUCTION DRAIN
K926408 · GBX
Sil-Med Corp.
General & Plastic Surgery · 408d
Cleared Feb 02, 1994
SIL-SLIP ROUND WOUND DRAIN (COATED)/BLUE STRIPE
K926495 · GBX
Sil-Med Corp.
General & Plastic Surgery · 400d
Cleared Feb 02, 1994
INTRODE INT-8
K930242 · GZB
Neuromed, Inc.
Neurology · 379d
Cleared Feb 02, 1994
LATHAM TABLE
K930692 · INQ
I-Rep, Inc.
Physical Medicine · 357d
Cleared Feb 02, 1994
HOT/ICE SYSTEM STERILE CONFORMABLE/DISP. BLANKETS
K931843 · ILO
Hollister, Inc.
Physical Medicine · 295d
Cleared Feb 02, 1994
OWENS TROCAR
K932796 · GCJ
Owens Industries, Inc.
General & Plastic Surgery · 238d