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
151897–151920 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 23, 1984
RODY BREAST PUMP
K840874 · HGY
Kean-Rody Manufacturer
Obstetrics & Gynecology · 147d
Cleared Jul 23, 1984
ESOPHAGEAL TUBE
K841349 · KNT
E. Benson Hood Laboratories, Inc.
Gastroenterology & Urology · 112d
Cleared Jul 23, 1984
HESUNG BLOOD TRANSFUSION SETS
K841562 · FPA
Amkor Trading Co.
General Hospital · 97d
Cleared Jul 23, 1984
WIRE
K841628 · HXN
Plastafil, Inc.
Orthopedic · 95d
Cleared Jul 23, 1984
INTRAVENOUS INJECTION SET
K841717 · FPA
Philadelphia Biologics Center
General Hospital · 89d
Cleared Jul 23, 1984
SINGLE HAIR TRANSPLANT GRAFT
K841741 · FZT
Paris Products, Inc.
General & Plastic Surgery · 91d
Cleared Jul 23, 1984
FIRST RESPONSE EMERG. MEDICAL SYSTEM
K841897 · KGX
Reed Products, Inc.
General & Plastic Surgery · 77d
Cleared Jul 23, 1984
FIRST RESPONSE EMERG. MEDICAL SYS BONES
K841899 · KGX
Reed Products, Inc.
General & Plastic Surgery · 77d
Cleared Jul 23, 1984
FIRST RESPONSE EMERG. EYE INJURIES
K841900 · LRR
Reed Products, Inc.
General & Plastic Surgery · 77d
Cleared Jul 23, 1984
OXYMIZER FLOW RESTRICTOR
K841901 · BYX
Chad Therapeutics, Inc.
Anesthesiology · 77d
Cleared Jul 23, 1984
NEUTRAL POS-CHAIR SURGEON CHAIR
K842030 · FZK
Neutral Pos-Chair Co.
General & Plastic Surgery · 66d
Cleared Jul 23, 1984
DISPOS. ACU-CUT SOFT TISSUE BIOPSY
K842091
The Healthcare Group Laboratories, Inc.
General & Plastic Surgery · 60d
Cleared Jul 23, 1984
PMS SUTURE PACK/TRAY
K842149
Professional Medical Services
General & Plastic Surgery · 54d
Cleared Jul 23, 1984
AIMED DISPOSABLE SYRINGE, VARIOUS SIZES
K842227 · FMF
Tech-Cons Ltd., Intl.
General Hospital · 48d
Cleared Jul 23, 1984
ULTRASOUND PROBE COVERS-STERILE
K842591 · IYO
Applied Medical Devices, Inc.
Radiology · 20d
Cleared Jul 23, 1984
INFANT PERCUSSOR PA-010
K842608 · BYI
Alpha Medical Systems
Anesthesiology · 18d
Cleared Jul 23, 1984
BUTTERFLY II PN INFUSION NEEDLE
K842756 · FMI
Cosmetic Sciences, Inc.
General Hospital · 7d
Cleared Jul 20, 1984
EEG BIOFEEDBACK DEVICE ACCESSORY
K842021 · HCC
Electronics Research & Production
Neurology · 63d
Cleared Jul 20, 1984
EEG BIOFEEDBACK DEVICE
K842022 · HCC
Electronics Research & Production
Neurology · 63d
Cleared Jul 20, 1984
TEMP. & GSR BIOFEEDBACK DEVICE
K842023 · HCC
Electronics Research & Production
Neurology · 63d
Cleared Jul 20, 1984
BENT WINGED MINI-VOL INFUSION SET
K842143 · FPA
Med Fusion Systems, Inc.
General Hospital · 51d
Cleared Jul 20, 1984
CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT
K842151 · LKH
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 51d
Cleared Jul 20, 1984
NEW JERSEY ACETABULAR COMPONENT &
K842202 · JDI
Endomedics, Inc.
Orthopedic · 46d
Cleared Jul 20, 1984
NEW JERSEY FEMORAL RESURFACING COMPONENT
K842233 · KXA
Endomedics, Inc.
Orthopedic · 45d