Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
57889–57912 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 2007
DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE...
K071746 · KGO
Ansell Healthcare Products, LLC
General Hospital · 169d
Cleared Dec 13, 2007
SMARTPORT CT MP PORT ACCESS SYSTEM AND LIFEGUARD CT SAFETY INFUSION SET
K072375 · FPA
AngioDynamics, Inc.
General Hospital · 112d
Cleared Dec 13, 2007
SWABABLE VIAL ADAPTER 13MM, SWABABLE VIAL ADAPTER 20MM
K072511 · LHI
Medimop Medical Projects, Ltd.
General Hospital · 98d
Cleared Dec 13, 2007
EDTA PLUS
K072555 · KJJ
Essential Dental Systems, Inc.
Dental · 94d
Cleared Dec 13, 2007
GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM
K072594 · FGA
Gyrus Acmi, Inc.
Gastroenterology & Urology · 90d
Cleared Dec 13, 2007
ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH...
K072621 · BZT
Cincinnati Sub-Zero Products, Inc.
Anesthesiology · 87d
Cleared Dec 13, 2007
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)
K072625 · LJS
Cook, Inc.
General Hospital · 87d
Cleared Dec 13, 2007
MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER
K072670 · CAF
Pari Innovative Manufacturers, Inc.
Anesthesiology · 83d
Cleared Dec 13, 2007
VIAL2BAG
K072759 · LHI
Medimop Medical Projects, Ltd.
General Hospital · 76d
Cleared Dec 13, 2007
ISSYS LP SPINAL FIXATION SYSTEM
K072866 · KWP
Custom Spine, Inc.
Orthopedic · 69d
Cleared Dec 13, 2007
ION MEDICAL BIPOLAR COAGULATION PEN
K072911 · GEI
Ion Medical, LLC
General & Plastic Surgery · 62d
Cleared Dec 13, 2007
MIRAGE MICRO
K072940 · BZD
Resmed, Ltd.
Anesthesiology · 57d
Cleared Dec 13, 2007
SMH FLEX S
K073040 · EBI
Smh Biomaterial AG
Dental · 45d
Cleared Dec 13, 2007
SCREWPLUS DENTAL IMPLANTS (HA)
K073049 · DZE
Implant Direct, LLC
Dental · 45d
Cleared Dec 13, 2007
BEACON STABILIZATION SYSTEM
K073172 · NKB
Globus Medical, Inc.
Orthopedic · 30d
Cleared Dec 12, 2007
DISPOSABLE POWDERED VINYL EXAM GLOVE, YELLOW COLOR
K071122 · LYZ
Xuzhou Full Sun Medical Products , Ltd.
General Hospital · 233d
Cleared Dec 12, 2007
TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015...
K071150 · ETD
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 231d
Cleared Dec 12, 2007
ALCON MULTI-PURPOSE SOLUTION
K071236 · LPN
Alcon, Inc.
Ophthalmic · 223d
Cleared Dec 12, 2007
NEUROSIGN LARYNGEAL ELECTRODES
K071349 · ETN
The Magstim Company , Ltd.
Ear, Nose, Throat · 212d
Cleared Dec 12, 2007
THE INVACARE FLYER, MODEL IPC 100
K071928 · CAW
Invacare Corp.
Anesthesiology · 153d
Cleared Dec 12, 2007
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR
K072314 · LYZ
Xuzhou Full Sun Medical Products , Ltd.
General Hospital · 117d
Cleared Dec 12, 2007
K-Y BRAND INTRIGUE INTENSE WARMING SENSATION
K072360 · NUC
Mcneil-Ppc, Inc.
Obstetrics & Gynecology · 112d
Cleared Dec 12, 2007
PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS
K072376 · HIL
Playtex Products, Inc.
Obstetrics & Gynecology · 110d
Cleared Dec 12, 2007
ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000
K072450 · CBK
Respironics California, Inc.
Anesthesiology · 103d