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
135625–135648 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 15, 1988
MX1002 CABLE-CAL TM
K880696 · DXG
Medex, Inc.
Cardiovascular · 114d
Cleared Jun 15, 1988
BIOLOGICAL OHM METER, BES 200Z
K880926 · DSB
Bioelectrical Sciences, Inc.
Cardiovascular · 103d
Cleared Jun 15, 1988
EDWARDS-DUROMEDICS LEAFLET PROBE, MODEL 1116
K881449 · LXN
Baxter Healthcare Corp
Cardiovascular · 71d
Cleared Jun 15, 1988
EMBOLECTOMY CATHETER(MODIFIED)
K881455 · DXE
Cathlab Corp.
Cardiovascular · 70d
Cleared Jun 15, 1988
OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM403C
K881601 · DXN
Omron Tateisi Electronics Co.
Cardiovascular · 63d
Cleared Jun 15, 1988
OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM703C
K881602 · DXN
Omron Tateisi Electronics Co.
Cardiovascular · 63d
Cleared Jun 15, 1988
SURGICAL BLADE
K881638 · GES
Far East Intl. Trading Corp.
General & Plastic Surgery · 62d
Cleared Jun 15, 1988
MANAN TABAR-ROTHSCHILD GALACTOGRAPHY KIT
K881671 · FMI
Manan Medical Devices
Radiology · 58d
Cleared Jun 15, 1988
EASY WASHER II MICROPLATE WASHER
K881797 · JJQ
Slt Labinstruments, Inc.
Chemistry · 49d
Cleared Jun 15, 1988
SURGICAL INSTRUMENTS
K881937 · HRQ
Far East Intl. Trading Corp.
General & Plastic Surgery · 37d
Cleared Jun 15, 1988
BICARBONATE (CO2) REAGENT-2 VIAL
K881938 · KHS
Trace Scientific , Ltd.
Chemistry · 37d
Cleared Jun 15, 1988
SOFT TISSUE BIOPSY DEVICE
K882013 · DWO
Ocean Medical Products, Ltd.
General & Plastic Surgery · 33d
Cleared Jun 15, 1988
ADD-A-SHIELD
K882026 · FXX
Bfd, Inc.
General Hospital · 33d
Cleared Jun 15, 1988
COMBO-SHIELD
K882027 · FXX
Bfd, Inc.
General Hospital · 33d
Cleared Jun 15, 1988
COVERALL SHIELD
K882028 · FXX
Bfd, Inc.
General Hospital · 33d
Cleared Jun 15, 1988
MURSE RETRACTOR
K882112 · GAD
Euro-American Marketing Group, Inc.
General & Plastic Surgery · 27d
Cleared Jun 15, 1988
TECNOL TIGER PAWS PRODUCT NUMBER 47705-010
K882128 · FXP
Tecnol New Jersey Wound Care, Inc.
General Hospital · 26d
Cleared Jun 15, 1988
LIGHT, SURGICAL ACCESSORIES
K882132 · FTA
Charles Polo & Co., Inc.
General & Plastic Surgery · 26d
Cleared Jun 15, 1988
JEDMED MICRO CCD CAMERA SYSTEM
K882166 · FWD
Jedmed Instrument Co.
General & Plastic Surgery · 22d
Cleared Jun 15, 1988
ZINC FORMALIN CONCENTRATE
K882268 · IGG
Anatech, Ltd.
Pathology · 15d
Cleared Jun 14, 1988
HOUSE DUST
K875110 · DHB
Incstar Corp.
Immunology · 183d
Cleared Jun 14, 1988
AUTO-VAC INTRAOPERATIVE AUTOTRANS. RESERVOIR #7904
K881129 · CAC
Boehringer Laboratories
Anesthesiology · 90d
Cleared Jun 14, 1988
MUCUS TRAP OR SUCTION TRAP
K881149 · KDQ
Ferguson Medical
General Hospital · 89d
Cleared Jun 14, 1988
ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER
K881220 · HFE
Laboratoire Ccd C/O Washington...
Obstetrics & Gynecology · 84d