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
94585–94608 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 11, 1997
TRACH CARE SET WITH MICROBAN
K964369 · BSY
Ballard Medical Products
Anesthesiology · 102d
Cleared Feb 11, 1997
ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST
K964461 · JHI
Teco Diagnostics
Chemistry · 96d
Cleared Feb 11, 1997
ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST
K964462 · JHI
Teco Diagnostics
Chemistry · 96d
Cleared Feb 11, 1997
ONE-STEP DIPSTICK PREGNANCY TEST
K964536 · JHI
Teco Diagnostics
Chemistry · 91d
Cleared Feb 11, 1997
OSTEONICS SPINAL SYSTEM - VARIABLE OFFSET CONNECTOR ASSEMBLY
K964544 · MNH
Osteonics Corp.
Orthopedic · 90d
Cleared Feb 11, 1997
ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR...
K964561 · FDG
Bioenterics Corp.
Gastroenterology & Urology · 90d
Cleared Feb 11, 1997
SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO,...
K964657 · ESD
Micro-Ear Technology, Inc.
Ear, Nose, Throat · 83d
Cleared Feb 11, 1997
PHASED ARRAY NECK COIL
K964678 · MOS
Philips Medical Systems (Cleveland),...
Radiology · 82d
Cleared Feb 11, 1997
AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION
K964697 · DXN
Advance Medical Device, Inc.
Cardiovascular · 81d