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
135025–135048 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 16, 1988
VITEK YEAST BIOCHEMICAL CARD
K881925 · JXB
Vitek Systems, Inc.
Microbiology · 38d
Cleared Jun 16, 1988
SUCTION RETRACTORS
K882074 · GAD
Karlin Technology, Inc.
General & Plastic Surgery · 30d
Cleared Jun 16, 1988
SELF-RETAINING SOFT TISSUE RETRACTOR
K882075 · GAD
Karlin Technology, Inc.
General & Plastic Surgery · 30d
Cleared Jun 16, 1988
SPINAL SURGERY FRAME
K882078 · FWZ
Karlin Technology, Inc.
General & Plastic Surgery · 30d
Cleared Jun 16, 1988
RESUSCITATION BAG CONTROLLER (RBC)
K882278 · BTM
Physician Engineered Products, Inc.
Anesthesiology · 15d
Cleared Jun 16, 1988
KODAK EKTASCAN LASER PRINTER ADAPTER, MODEL M6/M8
K882320 · IXW
Eastman Kodak Company
Radiology · 10d
Cleared Jun 16, 1988
DISPOSABLE SYRINGE
K882335 · FMF
Baxter Healthcare Corp
General Hospital · 10d
Cleared Jun 16, 1988
MICROSCOPE SLIDES PRECOATED W/HISTOGRIP & POLY-LY
K882357 · KEW
Stat Path
Pathology · 9d
Cleared Jun 15, 1988
MONITRON SYSTEM
K874148 · DRT
American Health Products, Inc.
Cardiovascular · 246d
Cleared Jun 15, 1988
CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEM
K880353 · GKR
Ciba Corning Diagnostics Corp.
Chemistry · 141d
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