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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
98425–98448 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 22, 1996
MULTI III, IV
K955860 · LIH
Excel Tech. , Ltd.
Neurology · 86d
Cleared Mar 22, 1996
SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE
K955869 · MAV
Scimed Life Systems, Inc.
Cardiovascular · 87d
Cleared Mar 22, 1996
HOWMEDICA ASYMMETRIC STEM FEMORAL COMPONENT
K955871 · LPH
Howmedica Corp.
Orthopedic · 87d
Cleared Mar 22, 1996
ALTACARE
K955874 · FNM
Asf Industries, Inc.
General Hospital · 85d
Cleared Mar 22, 1996
RETINOL BINDING RID KIT
K955881 · CZS
The Binding Site, Ltd.
Immunology · 85d
Cleared Mar 22, 1996
900UDX URINE PATHOLOGY SYSTEM
K960054 · KQO
Intl. Remote Imaging Systems
Hematology · 78d
Cleared Mar 22, 1996
CPR GENERAL SURGERY TRAY
K960241 · LWI
Custom Pack Reliability
General & Plastic Surgery · 66d
Cleared Mar 22, 1996
DOCUMENT TDM ULTRA ASSAYED CONTROL
K960244 · DIF
Casco Standards
Chemistry · 66d
Cleared Mar 22, 1996
LONG LIFE RX-12
K960295 · ESD
Rexton, Inc.
Ear, Nose, Throat · 60d
Cleared Mar 22, 1996
ALTA CFX IM ROD SYSTEM
K960524 · HSB
Howmedica Corp.
Orthopedic · 46d
Cleared Mar 22, 1996
ACORN ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE
K960565 · EBF
Dent Zar, Inc.
Dental · 42d
Cleared Mar 22, 1996
BINAX STREP A TEST
K960712 · GTZ
Binax, Inc.
Microbiology · 30d
Cleared Mar 22, 1996
AMALGAMIBOND PLUS
K960879 · KLE
Parkell, Inc.
Dental · 18d
Cleared Mar 21, 1996
IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS
K946168 · LZH
Ivac Corporation
General Hospital · 458d
Cleared Mar 21, 1996
EC-3800L, VIDEO COLONOSCOPE
K951574 · FDF
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 352d
Cleared Mar 21, 1996
ES-3800, VIDEO SIGMOIDOSCOPE
K951577 · FAM
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 352d
Cleared Mar 21, 1996
EC-3800TL, VIDEO COLONOSCOPE
K951579 · FDF
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 352d
Cleared Mar 21, 1996
LASERFLO BLOOD PERFUSION SINGLE USE PROBES MODELS SUP-440, SUPR-434 SUP-433
K951832 · DPT
Vasamedics, LLC
Cardiovascular · 336d
Cleared Mar 21, 1996
INNOVASIVE 1.9MM ROC SUTURE BONE FASTENER
K954338 · MBI
Innovasive Devices, Inc.
Orthopedic · 185d
Cleared Mar 21, 1996
DELTA 16
K955411 · IZH
Instrumentarium Imaging, Inc.
Radiology · 115d
Cleared Mar 21, 1996
VASCULAR ACCESS PORT KIT
K955587 · LJT
Boston Scientific Corp
General Hospital · 105d
Cleared Mar 21, 1996
ALCON SERIES 20000 LEGACY MACKOOL SYSTEM
K955789 · HQC
Alcon Laboratories
Ophthalmic · 90d
Cleared Mar 21, 1996
PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAY
K955790 · HIC
Trylon Corp.
Obstetrics & Gynecology · 90d
Cleared Mar 21, 1996
DUAL SPRAY MINISPACER
K955805 · CAF
Thayer Medical Corp.
Anesthesiology · 90d