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
135409–135432 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 11, 1988
ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP.
K874861 · DPT
Acuson Computed Sonography
Cardiovascular · 166d
Cleared May 11, 1988
WALNUT ALLERGEN DISC
K874883 · DHB
Incstar Corp.
Immunology · 162d
Cleared May 11, 1988
ARTIS 3200 DIAGNOSTIC ULTRASOUND DEVICE
K875251 · IYO
Philips Medical Systems (Cleveland),...
Radiology · 141d
Cleared May 11, 1988
BIONICA MDS 110 PCA
K875316 · FRN
Bionica, Inc.
General Hospital · 134d
Cleared May 11, 1988
INCSTAR'S BIRCH ALLERGEN DISC
K880168 · DHB
Incstar Corp.
Immunology · 117d
Cleared May 11, 1988
INCSTAR'S PIGWEED ALLERGEN DISC
K880221 · DHB
Incstar Corp.
Immunology · 112d
Cleared May 11, 1988
PALLADIUM-BASED DENTAL ALLOYS FOR PORCELAIN APPLI.
K880348 · EJT
J.F. Jelenko & Co., Inc.
Dental · 106d
Cleared May 11, 1988
ROTA-DENT TOOTH CLEANER
K880589 · JEQ
Pro-Dentec
Dental · 90d
Cleared May 11, 1988
SHILEY BCD PLUS HEAT EXCHANGER
K880663 · DTR
Shiley, Inc.
Cardiovascular · 83d
Cleared May 11, 1988
XR PRIMER
K880684 · KLE
Kerr Corporation (Danbury)
Dental · 82d
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