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
150985–151008 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 1984
CURITY SILICONE NEPHROSTOMY CATHETER
K842840 · LJE
The Kendal Co.
Gastroenterology & Urology · 76d
Cleared Oct 04, 1984
MEDIFLEX DRAINAGE BAG
K843126 · KNX
Mediflex Intl.
Gastroenterology & Urology · 55d
Cleared Oct 04, 1984
SEXTON CYSTOTOMY URINE PUMP
K843158 · KOB
Holter-Hausner Intl.
Gastroenterology & Urology · 55d
Cleared Oct 04, 1984
VIDEO URODYNAMICS SYS 1906B-Y & 1906C-Y
K843198 · FET
Life-Tech Intl., Inc.
Gastroenterology & Urology · 51d
Cleared Oct 04, 1984
NEW ALLERG. COATED MICROFILTER WELL STRI
K843302 · DHB
Diagnostic Reagent Tech.
Immunology · 42d
Cleared Oct 04, 1984
ENCORE HCG REAGENT
K843407 · JHI
Hybritech, Inc.
Chemistry · 34d
Cleared Oct 04, 1984
TUBE-STAT
K843490 · BSR
Concept, Inc.
Anesthesiology · 28d
Cleared Oct 04, 1984
BALLOON DILATION CATHETER
K843501 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 28d
Cleared Oct 04, 1984
WAREXIN RECOMMENDED ALTERNATIVE DIALYZ
K843520 · LIF
Mesa Medical, Inc.
Gastroenterology & Urology · 27d
Cleared Oct 04, 1984
LINDER NASOPHARYNGEAL AIRWAY
K843524 · BTQ
Polamedco, Inc.
Anesthesiology · 28d
Cleared Oct 04, 1984
OHMEDA MODEL 5200 CO2 MONITOR
K843599 · CCK
Ohmeda Medical
Anesthesiology · 22d
Cleared Oct 04, 1984
COTTON TIPPED APPLICATORS, SINGLE
K843720 · KXF
Abco Dealers, Inc.
General Hospital · 10d
Cleared Oct 04, 1984
PNEUPAC INSTANT ACTION VENTILATOR/RESUS
K843737 · CBK
Pneupac , Ltd.
Anesthesiology · 9d
Cleared Oct 04, 1984
OHMEDA RM311 RESPIROMETER
K843799 · BZK
Ohmeda Medical
Anesthesiology · 7d
Cleared Oct 04, 1984
OHMEDA RM121 RESPIROMETER
K843800 · BZK
Ohmeda Medical
Anesthesiology · 7d
Cleared Oct 04, 1984
BUNN 3001 OXYGEN CONCENTRATOR
K843811 · CAW
The John Bunn Co.
Anesthesiology · 6d
Cleared Oct 02, 1984
MODELS 78551A 78552A
K841256 · DXG
Hewlett-Packard Co.
Cardiovascular · 214d
Cleared Oct 02, 1984
HEART RATE/RESPIRATION SIMULATOR 8310
K841363 · DRT
Aequitron Medical, Inc.
Cardiovascular · 183d
Cleared Oct 02, 1984
48 HOUR BIOLOGICAL INDICATORS SPORSTRIP
K841709 · FRC
Skyland Scientific Services, Inc.
General Hospital · 162d
Cleared Oct 02, 1984
CATH-TECH CHOLANGIOGRAPHY CATHETER
K842147 · FGE
Catheter Technology Corp.
Gastroenterology & Urology · 125d
Cleared Oct 02, 1984
DIAFLEX NEPHROSTOMY BALLOON DILATOR
K842206 · EZN
American Edwards Laboratories
Gastroenterology & Urology · 120d
Cleared Oct 02, 1984
HEMODIAL CONCENTRATE MIXING APPARATUS
K842225 · FKQ
Lmf Medical Research & Manufacturing,...
Gastroenterology & Urology · 119d
Cleared Oct 02, 1984
DORR HIP PROSTHESIS FEMORAL COMPONENT
K842360 · JDI
Carbomedics, Inc.
Orthopedic · 117d
Cleared Oct 02, 1984
METER MOUSE SYSTEM
K842599
Mem, Inc.
Radiology · 91d