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
149905–149928 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 15, 1985
OLYMPUS PF-27M FLEXIBLE URETERORENOSCOPE
K844143 · FGB
Olympus Corp.
Gastroenterology & Urology · 84d
Cleared Jan 15, 1985
CONTINENT STOMA SYSTEM & ACCESSORIES
K844186 · KBG
Chesebrough-Pond'S U.S.A. Co.
Ear, Nose, Throat · 78d
Cleared Jan 15, 1985
PERRY SUTURING SET
K844609
Perry, Div.
General & Plastic Surgery · 49d
Cleared Jan 15, 1985
RIGID FIBEROPITC ENDOSCOPE
K844769 · GCM
Microvasive
Gastroenterology & Urology · 39d
Cleared Jan 15, 1985
ULTRA EXTERNAL CATHETER
K844801 · KNX
Inmed Corp.
Gastroenterology & Urology · 35d
Cleared Jan 15, 1985
CHESEBROUGH-POND'S URI-DRAIN MALE URINARY POUCH
K845010 · EYQ
Chesebrough-Pond'S U.S.A. Co.
Gastroenterology & Urology · 20d
Cleared Jan 15, 1985
DAVOL PAPILLITOME
K845015 · KNS
C.R. Bard, Inc.
Gastroenterology & Urology · 20d
Cleared Jan 15, 1985
DAVOL POLYPECTOMY SNARE
K845016 · FDI
C.R. Bard, Inc.
Gastroenterology & Urology · 20d
Cleared Jan 15, 1985
DAVOL RETRIEVAL BASKETS & FORCEPS
K845017 · OCZ
C.R. Bard, Inc.
Gastroenterology & Urology · 20d
Cleared Jan 15, 1985
DAVOL ERCP CANNULA
K845018 · ODD
C.R. Bard, Inc.
Gastroenterology & Urology · 20d
Cleared Jan 15, 1985
NEPHROSTOMY GUIDEWIRE SHEATH
K845047 · LJE
American Edwards Laboratories
Gastroenterology & Urology · 15d
Cleared Jan 15, 1985
NEPHROSTOMY DRAINAGE CATHETER & STIFFENER
K845048 · LJE
American Edwards Laboratories
Gastroenterology & Urology · 15d
Cleared Jan 14, 1985
SAT-1 OXIMETER/CARDIAC OUTPUT COMPUTER
K841401 · DXG
American Edwards Laboratories
Cardiovascular · 286d
Cleared Jan 14, 1985
ERYTHROCATH UMBILICAL CATHETER
K841880 · FOZ
Cardio Search, Inc.
General Hospital · 252d
Cleared Jan 14, 1985
LEE SYRINGE
K842371
Peter F. Lee, Inc.
Dental · 213d
Cleared Jan 14, 1985
DUAL CHANNEL TENS, PULSAR REMOTE CONTRL
K842888 · GZJ
Cryomedics, Inc.
Neurology · 175d
Cleared Jan 14, 1985
SHILEY HARDSHELL VENOUS RESERVOIR W/INT
K843232 · DTN
Shiley, Inc.
Cardiovascular · 150d
Cleared Jan 14, 1985
NUMED BALLOON PACING CATHETER
K843290 · LDF
NuMED, Inc.
Cardiovascular · 146d
Cleared Jan 14, 1985
ADD-A-VIAL SOLUTION TRANSFER DEVICE
K843639 · LHI
American Mcgaw
General Hospital · 119d
Cleared Jan 14, 1985
XENON XE 127/XE 133 GAS DISPENSER
K843640 · IYT
Mallinckrodt Critical Care
Radiology · 119d
Cleared Jan 14, 1985
CASTLE 7515 UTENSIL/GLASSWARE WASHER
K844089 · LDS
Castle Co.
General Hospital · 84d
Cleared Jan 14, 1985
SYRINGE W/NEEDLE COMBIN & SYRINGE ONLY
K844106 · FMF
Abco Dealers, Inc.
General Hospital · 83d
Cleared Jan 14, 1985
VENOUS RESERVOIR VRS-XXX SERIES
K844229 · DTN
Gish Biomedical, Inc.
Cardiovascular · 74d
Cleared Jan 14, 1985
CARDIOTOMY RESERVOIR BCR-2000
K844366 · DTN
American Bentley
Cardiovascular · 62d