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
119569–119592 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 1991
ELITE R 90/15
K912741 · IXR
Fischer Imaging Corp.
Radiology · 105d
Cleared Oct 04, 1991
DIMENSION-HA HIP PROSTHESIS
K912922 · MEH
Kirschner Medical Corp.
Orthopedic · 93d
Cleared Oct 04, 1991
COMPRESS DRESSING
K912950 · NAB
Cal West Trading Co.
General & Plastic Surgery · 94d
Cleared Oct 04, 1991
BANDAGE COMPRESS
K912952 · NAB
Cal West Trading Co.
General & Plastic Surgery · 94d
Cleared Oct 04, 1991
CONCEPT MICROMILL
K912957 · HRX
Concept, Inc.
Orthopedic · 88d
Cleared Oct 04, 1991
HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION
K912979 · KHE
Labeltape Meditect, Inc.
Hematology · 123d
Cleared Oct 04, 1991
SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION
K913038 · DSH
Spacelabs, Inc.
Cardiovascular · 87d
Cleared Oct 04, 1991
SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT
K913294 · GCA
Surgitek Medical Engineering Corp.
Gastroenterology & Urology · 72d
Cleared Oct 04, 1991
SILICONE MALE EXTERNAL CATHETER
K913524 · EXJ
Mentor Corp.
Gastroenterology & Urology · 57d
Cleared Oct 04, 1991
MEMOSIL C.D.
K913537 · ELW
Heraeus Kulzer, Inc.
Dental · 56d
Cleared Oct 04, 1991
THORACIC CATHETER STYLET
K913543 · DRB
Intl. Medical Devices , Ltd.
Cardiovascular · 56d
Cleared Oct 04, 1991
WELLPREP 1
K913567 · JQW
Denley Instruments, Inc.
Chemistry · 56d
Cleared Oct 04, 1991
DISPOSABLE SHOE COVER
K913628 · FXP
Gem Nonwovews, Inc.
General Hospital · 50d
Cleared Oct 04, 1991
DISPOSABLE BOUFFANT CAP
K913700 · FYF
Gem Nonwovews, Inc.
General & Plastic Surgery · 46d
Cleared Oct 04, 1991
MEDA CROWN SERIES
K913800 · GZJ
Medical Electronic Assn.
Neurology · 44d
Cleared Oct 04, 1991
FIXATION DEVICES AND BONE PLATE
K913930 · HRS
John M. Rayhack
Orthopedic · 43d
Cleared Oct 04, 1991
GRASPER, RATCHETED (5MM X 30CM)
K913991 · GCJ
Northgate Technologies, Inc.
General & Plastic Surgery · 29d
Cleared Oct 03, 1991
BEDSIDE FLUID MANAGEMENT SYSTEM 1000 (FMS-1000)
K910323 · FLN
Uab Research Foundation
General Hospital · 252d
Cleared Oct 03, 1991
MODEL #350 SHOCK-PLATE DEFIB ADAPTOR
K911402 · LDD
Cardiotronics, Inc.
Cardiovascular · 188d
Cleared Oct 03, 1991
ITM SONIC SURGERY SYSTEM
K912931 · JDX
Buckman Co., Inc.
Orthopedic · 90d
Cleared Oct 03, 1991
BIODEX SYSTEM 2,MODEL S2-S
K913020 · IKK
Biodex Corp.
Physical Medicine · 86d
Cleared Oct 03, 1991
BIODEX,MODEL B-2000
K913021 · IKK
Biodex Corp.
Physical Medicine · 86d
Cleared Oct 02, 1991
WALTER GRAPHTEK
K910972 · GWQ
Inomed Medizintechnik GmbH
Neurology · 209d
Cleared Oct 02, 1991
PNEU-WAVE
K911574 · JFB
Pneu-Mobility, Inc.
Physical Medicine · 177d