FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
136009–136032 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 11, 1988
PORCELITE DUAL CURE CEMENT
K880685 · EMA
Kerr Corporation (Danbury)
Dental · 82d
Cleared May 11, 1988
MEDSURG MYELOGRAM TRAY
K880693 · FMF
Medsurg Industries, Inc.
General Hospital · 79d
Cleared May 11, 1988
DATALOGGER CHART RECORDER
K880781 · DSF
Air-Shields, Inc.
Cardiovascular · 75d
Cleared May 11, 1988
EXAMIX DISPENSER
K880849 · EKJ
G-C Intl. Corp.
Dental · 71d
Cleared May 11, 1988
THE S.A.F.E. SYSTEM
K880890 · FYD
Pfizer Laser Systems
General Hospital · 70d
Cleared May 11, 1988
M424 EMG MONITOR
K880913 · HCC
Bio-Logic Devices
Neurology · 69d
Cleared May 11, 1988
T824 TEMPERATURE MONITOR
K880914 · HCC
Bio-Logic Devices
Neurology · 69d
Cleared May 11, 1988
M444 EMG MONITOR
K880916 · HCC
Bio-Logic Devices
Neurology · 69d
Cleared May 11, 1988
SNOAR(TM) OPEN AIRWAY APPLIANCE
K880956 · LQZ
Kent J. Toone, D.D.S.
Dental · 65d
Cleared May 11, 1988
AMALGAMATOR
K880993 · EFD
Acecodent, Inc.
Dental · 64d
Cleared May 11, 1988
TRU-TECH 310 ULTRASOUND THERAPY UNIT #310
K881211 · IMI
Tru-Trac Therapy Products, Inc.
Physical Medicine · 51d
Cleared May 11, 1988
TORAY ANTHRON P-U CATHETERS
K881236 · FOZ
Toray Industries (America), Inc.
General Hospital · 50d
Cleared May 11, 1988
IMX FERRITIN
K881345 · DGD
Abbott Laboratories
Immunology · 42d
Cleared May 11, 1988
AUDIOTONE MODEL A-61 BEHIND-THE-EAR HEARING AID
K881652 · ESD
Audiotone, Inc.
Ear, Nose, Throat · 26d
Cleared May 11, 1988
INFUSE-A-PORT RADIOPAQUE POLYURETHANE CATHETER
K881745 · LJT
Shiley Infusaid, Inc.
General Hospital · 19d
Cleared May 11, 1988
MODIFIED MODEL 2100 ND:YAG LASER
K881848 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 9d
Cleared May 10, 1988
PYTHON AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
K874917 · DXN
Oxford Medilog, Inc.
Cardiovascular · 159d
Cleared May 10, 1988
AIDS SAFETY BELT
K875068 · HIS
Aids Safety Belt, Inc.
Obstetrics & Gynecology · 154d
Cleared May 10, 1988
OHMEDA 2350 FINAPRES(R) BLOOD PRESSURE MONITOR
K880572 · DXN
Ohmeda Medical
Cardiovascular · 89d
Cleared May 10, 1988
LARGE LUMEN Y ADAPTER W/ROTATING DEVICE
K880831 · DTL
Interventional Medical, Inc.
Cardiovascular · 70d
Cleared May 09, 1988
(MB-650) BLOOD PRESSURE MONITOR
K880715 · DXN
Sharp Electronics Corp.
Cardiovascular · 90d
Cleared May 09, 1988
MEDSURG 16 GA. CENTRAL VEIN CATHETERIZATION TRAY
K880779 · DWF
Medsurg Industries, Inc.
Cardiovascular · 73d
Cleared May 09, 1988
ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK
K881618 · FXX
3M Company
General Hospital · 24d
Cleared May 06, 1988
ABBOTT TESTPACK RSV
K874127 · GQG
Abbott Laboratories
Microbiology · 206d