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
85033–85056 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 1999
RABEA DEVICE, MODEL PXXXXXX
K990345 · JDK
Signus Medizintechnik GmbH
Orthopedic · 176d
Cleared Jul 30, 1999
DENTEC LD 15 DIODE LASER
K990680 · GEX
Dentek Lasersystems Produktions...
General & Plastic Surgery · 150d
Cleared Jul 30, 1999
BIORC ANCHOR
K990770 · HWC
Linvatec Corp.
Orthopedic · 143d
Cleared Jul 30, 1999
POLARIS DIODE LASER SYSTEM AND ACCESSORIES
K990914 · GEX
Xintec Corporation
General & Plastic Surgery · 134d
Cleared Jul 30, 1999
ACIER SUTURES
K991073 · GAQ
Cardio Thoracic Systems
General & Plastic Surgery · 121d
Cleared Jul 30, 1999
FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW...
K991520 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 88d
Cleared Jul 30, 1999
TLC PEDIATRIC FRAME, MODEL TLC-SYS
K991523 · IYE
Radionics, Inc.
Radiology · 88d
Cleared Jul 30, 1999
CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS
K991535 · KPS
Hitachi Medical Corp. of America
Radiology · 88d
Cleared Jul 30, 1999
AKTINA MEDICAL PHYSICS CORPORATION TILT BOARD
K991546 · IYE
Aktina Medical Physics Corp.
Radiology · 88d
Cleared Jul 30, 1999
NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS)
K991581 · JWH
Zimmer, Inc.
Orthopedic · 84d
Cleared Jul 30, 1999
POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE POWDER FREE...
K991615 · LZA
Maxxim Medical
General Hospital · 81d
Cleared Jul 30, 1999
KOMET XK-95 PERFORATOR MOTOR (MI-102)
K991625 · HBB
Komet Medical
Neurology · 80d
Cleared Jul 30, 1999
ZIRCONIA 22.22MM CERAMIC MODULAR HEADS
K991708 · LZO
Biomet, Inc.
Orthopedic · 72d
Cleared Jul 30, 1999
SIDESTREAM NEBULIZER
K991725 · CAF
Inspired Medical Products , Ltd.
Anesthesiology · 71d
Cleared Jul 30, 1999
LACTOSORB HAND SYSTEM
K991763 · HRS
Biomet, Inc.
Orthopedic · 67d
Cleared Jul 30, 1999
ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03
K991870 · CGZ
A.P. Total Care, Inc.
Chemistry · 59d
Cleared Jul 30, 1999
EMS SURFACE MOUNT SCALER
K991874 · ELC
(Ems Sa) Electro Medical Systems
Dental · 58d
Cleared Jul 30, 1999
DERMAPHYLYX FOAM ISLAND DRESSING
K991933 · KMF
Dermaphylyx, Inc.
General & Plastic Surgery · 52d
Cleared Jul 30, 1999
ULTRASOUND SCANNER, MODEL TYPE 2101
K991937 · IYO
B & K Medical A/S
Radiology · 51d
Cleared Jul 30, 1999
CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL.
K991968 · MDA
Smith & Nephew, Inc.
General & Plastic Surgery · 49d
Cleared Jul 30, 1999
LAGLOVE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM...
K992018 · KGO
La Glove (M) Sdn. Bhd.
General Hospital · 44d
Cleared Jul 30, 1999
MAMEX
K992037 · IZH
Del Medical Imaging Corp.
Radiology · 44d
Cleared Jul 30, 1999
PULSTAR
K992061 · GEX
Lasermed, Inc.
General & Plastic Surgery · 42d
Cleared Jul 30, 1999
SCARAID SILICONE GEL SHEETING
K992146 · MDA
Biodermis Corp.
General & Plastic Surgery · 36d