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
92233–92256 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 1997
NPB-190 PULSE OXIMETER (NPB-190)
K971946 · DQA
Nellcor Puritan Bennett, Inc.
Anesthesiology · 90d
Cleared Aug 25, 1997
KODAK DIGITAL SCIENCE PRO-MEDICAL THERMAL PRINTER
K971973 · LLZ
Eastman Kodak Company
Radiology · 88d
Cleared Aug 25, 1997
SLEEP-IN BONE SCREW SYSTEM
K972023 · LRK
Influence, Inc.
Dental · 84d
Cleared Aug 25, 1997
NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC)
K972039 · ESD
Nu-Sound
Ear, Nose, Throat · 84d
Cleared Aug 25, 1997
THE YELLOW IRIS URINALYSIS WORKSTATION
K972141 · KQO
Intl. Remote Imaging Systems
Chemistry · 80d
Cleared Aug 25, 1997
ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATING
K972142 · DQX
Guidant Corp.
Cardiovascular · 80d
Cleared Aug 25, 1997
PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-2)
K972147 · ITI
Dynamic Systems, Inc.
Physical Medicine · 77d
Cleared Aug 25, 1997
OSTEO ANATOMICAL BONE PLATES
K972196 · HRS
Osteonics Corp.
Orthopedic · 76d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA O GROUP B
K972386 · GNC
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA O GROUP A
K972387 · GNC
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA O GROUP C
K972388 · GNC
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA H D
K972389 · GNC
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA H C
K972390 · GNC
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA H B
K972391 · GNC
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA H A
K972392 · GNC
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN BRUCELLA ABORTUS
K972394 · GSO
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA O GROUP D
K972395 · GNC
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN BRUCELLA MELITENSIS
K972396 · GSO
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Aug 25, 1997
EXTRAWEAR, GENTLEMEN'S CHOICE
K972428 · HIS
Custom Services Intl., Inc.
Obstetrics & Gynecology · 59d
Cleared Aug 25, 1997
TILT MASTER CG SYSTEM (CENTER OF GRAVITY), TILT-N-SPACE-SEAT
K972564 · ITI
Mechanical Application Designs, Inc.
Physical Medicine · 47d
Cleared Aug 25, 1997
RUFF WORK EYEGEAR
K972717 · HQY
Ruff House, Inc.
Ophthalmic · 35d
Cleared Aug 25, 1997
AURECAST 2
K972936 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 66d
Cleared Aug 25, 1997
AURECAST 4
K972937 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 66d
Cleared Aug 25, 1997
AURECAST 10
K972938 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 66d