FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
95089–95112 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 1997
VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESIS
K964769 · LPH
Zimmer, Inc.
Orthopedic · 78d
Cleared Feb 13, 1997
IN-TAC BONE ANCHOR SYSTEM
K964953 · HXJ
Influence, Inc.
Orthopedic · 70d
Cleared Feb 12, 1997
6 FRENCH, 7 FRENCH, AND 8 FRENCH GUIDING CATHETERS WITH PHOSPHORYLCHOLINE...
K962717 · DQY
Biocompatibles Cardiovascular, Inc.
Cardiovascular · 215d
Cleared Feb 12, 1997
BIONECT CREAM
K963004 · MGQ
Fidia Pharmaceutical Corp.
General & Plastic Surgery · 194d
Cleared Feb 12, 1997
TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD...
K963100 · LPH
Endotec, Inc.
Orthopedic · 187d
Cleared Feb 12, 1997
B-P HEMISPHERICAL ACETABULAR COMPONENT
K963101 · LPH
Endotec, Inc.
Orthopedic · 187d
Cleared Feb 12, 1997
TROCAR CANNULA
K963115 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 184d
Cleared Feb 12, 1997
BREATHE FIT
K963326 · LWF
Cambridge Assoc.
Ear, Nose, Throat · 173d
Cleared Feb 12, 1997
TRU-PULSE LASER (MODIFIED)
K963683 · GEX
Tissue Technologies, Inc.
General & Plastic Surgery · 167d
Cleared Feb 12, 1997
METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM
K963700 · HRS
Metagen, LLC
Orthopedic · 149d
Cleared Feb 12, 1997
CHOICE POWERED WHEELCHAIR
K963808 · ITI
American Medical Technology, Inc.
Physical Medicine · 142d
Cleared Feb 12, 1997
EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT
K964783 · CAZ
Alexander Medical, Inc.
Anesthesiology · 77d
Cleared Feb 12, 1997
IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING
K964846 · MDA
Implantech Associates, Inc.
General & Plastic Surgery · 71d
Cleared Feb 12, 1997
ANSPACH SUTURE ANCHOR
K965069 · MBI
The Anspach Effort, Inc.
Orthopedic · 61d
Cleared Feb 12, 1997
LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED,...
K965162 · GAM
Lukens Medical Corp.
General & Plastic Surgery · 50d
Cleared Feb 12, 1997
PASSY-MUIR O2 ADAPTER
K970365 · JOH
Passy-Muir, Inc.
Anesthesiology · 12d
Cleared Feb 11, 1997
EPI 2
K935706 · KCX
Universal H.R. System, Inc.
General & Plastic Surgery · 1169d
Cleared Feb 11, 1997
8500A PULSE OXIMETER
K945290 · DQA
Nonin Medical, Inc.
Anesthesiology · 834d
Cleared Feb 11, 1997
SAFE KNIGHTS
K955183 · HIS
L & N Corp.
Obstetrics & Gynecology · 456d
Cleared Feb 11, 1997
ULTRASOUND SYSTEM MODEL UF-3500
K955543 · IYO
Fukuda Denshi USA, Inc.
Radiology · 434d
Cleared Feb 11, 1997
HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2)
K960817 · MQS
Transonic Systems, Inc.
Gastroenterology & Urology · 349d
Cleared Feb 11, 1997
HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER
K963727 · ETD
Medtronic Xomed
Ear, Nose, Throat · 148d
Cleared Feb 11, 1997
STERI-OSS GOLD ATTACHMENT SYSTEM
K963945 · DZE
Steri-Oss, Inc.
Dental · 132d
Cleared Feb 11, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT /...
K964009 · DNO
Beckman Instruments, Inc.
Toxicology · 127d