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
96361–96384 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 1996
DRAGER MICRO VENT
K953238 · CBK
Drager, Inc.
Anesthesiology · 433d
Cleared Sep 16, 1996
CPR LIFE MASK COMPACT BARRIER
K954426 · CBP
Carefree Trading, Inc.
Anesthesiology · 360d
Cleared Sep 16, 1996
HELPING HAND
K954427 · ITI
Kinetic Rehabilitation Instruments, Inc.
Physical Medicine · 360d
Cleared Sep 16, 1996
DANTEC DUET
K960503 · FEN
Dantec Medical, Inc.
Gastroenterology & Urology · 227d
Cleared Sep 16, 1996
OLYMPUS MH-246R BALLOON SHEATH
K961048 · ODG
Olympus America, Inc.
Radiology · 185d
Cleared Sep 16, 1996
BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102
K961928 · FPA
Biomedix, Inc.
General Hospital · 122d
Cleared Sep 16, 1996
LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,363
K961941 · JJY
Bio-Rad
Chemistry · 119d
Cleared Sep 16, 1996
ENDOSONICS AUTOMATIC PULL BACK DEVICE
K962293 · ITX
Endosonics Corp.
Radiology · 94d
Cleared Sep 16, 1996
IN THE EAR HEARING AID
K962388 · ESD
Unique Hearing Technology, Inc.
Ear, Nose, Throat · 88d
Cleared Sep 16, 1996
EG-3800T, VIDEO GASTROSCOPE
K962460 · FDS
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 83d
Cleared Sep 16, 1996
[SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)]
K962506 · FJL
Gynecare Innovation Center
Gastroenterology & Urology · 81d
Cleared Sep 16, 1996
DRUG CALIBRATOR II
K962817 · DKB
Dade Intl., Inc.
Toxicology · 59d
Cleared Sep 16, 1996
MEDLINE RADIOLOGY-DIAGNOSTIC KITS
K962826 · LRO
Medline Industries, Inc.
Radiology · 59d
Cleared Sep 16, 1996
SELF RETAINING MALE EXTERNAL URINARY CATHETER
K962900 · EXJ
Hollister, Inc.
Gastroenterology & Urology · 53d
Cleared Sep 16, 1996
POLYPROPYLENE MESH (VARIOUS SIZES)
K962971 · FTL
Davis & Geck, Inc.
General & Plastic Surgery · 47d
Cleared Sep 13, 1996
MAHURKAR 8 FR DUAL LEMEN CATHETER
K955002 · MPB
Quinton, Inc.
Gastroenterology & Urology · 317d
Cleared Sep 13, 1996
CLEARVIEW C. DIFF A
K955067 · MCB
Unipath , Ltd.
Microbiology · 312d
Cleared Sep 13, 1996
LIQUITROL-TM, TUMOR MARKER CONTROL, LEVEL 1 AND 2
K961359 · JJY
Bioprocessing, Inc.
Immunology · 157d
Cleared Sep 13, 1996
TRACHEOSTOMY TUBES TRACOE-FLEX
K961449 · JOH
Tracoe Medical GmbH
Anesthesiology · 150d
Cleared Sep 13, 1996
NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIES
K962319 · IZD
Neoprobe Corp.
Radiology · 88d
Cleared Sep 13, 1996
DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR
K962629 · JIX
Casco Standards
Chemistry · 70d
Cleared Sep 13, 1996
STA-VWF CALIBRATOR KIT
K962671 · GJT
American Bioproducts Co.
Hematology · 66d
Cleared Sep 13, 1996
TOBRAMYCIN FLEX REAGENT CARTRIDGE
K962818 · LCR
Dade Intl., Inc.
Toxicology · 56d
Cleared Sep 13, 1996
GENTAMICIN FLEX REAGENT CARTRIDGE
K962819 · LCD
Dade Intl., Inc.
Toxicology · 56d