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

Cleared Jul 23, 1997

DEEG-LITE

K972202 · GWQ

Grass-Telefactor Product Group

Neurology · 42d

Cleared Jul 23, 1997

AMMONIA/IRON STANDARD KIT

K972333 · JIX

Verichem Laboratories, Inc.

Chemistry · 30d

Cleared Jul 23, 1997

MIRACLE-EAR DIGITAL BTE

K972344 · ESD

Miracle-Ear, Inc.

Ear, Nose, Throat · 29d

Cleared Jul 23, 1997

DAHLBERG/MIRACLE-EAR

K972345 · ESD

Miracle-Ear, Inc.

Ear, Nose, Throat · 29d

Cleared Jul 23, 1997

MIRACLE-EAR ITE DIGITAL

K972346 · ESD

Miracle-Ear, Inc.

Ear, Nose, Throat · 29d

Cleared Jul 23, 1997

MYRINGOTOMY TUBE - BOBBIN WITH TAB

K972400 · ETD

Mednet Locator, Inc.

Ear, Nose, Throat · 48d

Cleared Jul 23, 1997

MERIDIAN DSP

K972431 · ESD

Micro-Ear Technology, Inc.

Ear, Nose, Throat · 29d

Cleared Jul 23, 1997

JAZZ PP AGC-O, JAZZ PP

K972542 · ESD

Trutone

Ear, Nose, Throat · 14d

Cleared Jul 23, 1997

TWIST PPAGC-1, TWIST PP

K972543 · ESD

Trutone

Ear, Nose, Throat · 14d

Cleared Jul 22, 1997

CADPLAN, VERSION 2.62. RADIATION THERAPY TREATMENT PLANNING SYSTEM

K962950 · IYE

Varian Medical Systems, Inc.

Radiology · 358d

Cleared Jul 22, 1997

MODEL 6495 BIPOLAR TEMPORARY PACING LEAD

K963898 · LDF

Medtronic Vascular

Cardiovascular · 298d

Cleared Jul 22, 1997

TOX A/B TEST

K971182 · LLH

Techlab, Inc.

Microbiology · 113d

Cleared Jul 22, 1997

CRYO CHECK FACTOR V DEFICIENT PLASMA

K971223 · GJT

Precision Biologicals, Inc.

Hematology · 111d

Cleared Jul 22, 1997

BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000

K971437 · NYN

Murray Electronics

Neurology · 95d

Cleared Jul 22, 1997

QUANTA LITE RUBEOLA (MEASLES) IGG

K971620 · LJB

Inova Diagnostics, Inc.

Microbiology · 82d

Cleared Jul 22, 1997

LIQUID GLUCOSE (HEXOKINASE) REAGENT SET

K971754 · CFR

Pointe Scientific, Inc.,

Chemistry · 71d

Cleared Jul 22, 1997

PERSONALLAB AUTOMATED MICROPLATE ANALYZER

K971761 · JJE

Biochem Immunosystems (U.S.), Inc.

Chemistry · 71d

Cleared Jul 22, 1997

LAPAROSCOPIC BLADDER NECK SUSPENSION KIT

K971797 · HET

Louisville Laboratories, Inc.

Obstetrics & Gynecology · 68d

Cleared Jul 22, 1997

LAPAROTOMY BLADDER NECK SUSPENSION KIT

K971801 · EZL

Louisville Laboratories, Inc.

Gastroenterology & Urology · 68d

Cleared Jul 22, 1997

OPUS ETHANOL

K972011 · DIC

Behring Diagnostics, Inc.

Toxicology · 53d

Cleared Jul 22, 1997

EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5)

K972041 · LBS

Sigma Diagnostics, Inc.

Chemistry · 50d

Cleared Jul 22, 1997

VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE)

K972404 · KJA

Bd Becton Dickinson Vacutainer...

Pathology · 26d

Cleared Jul 21, 1997

CPROTECTOR 2000

K960587 · CBP

Certified Safety Mfg., Inc.

Anesthesiology · 525d

Cleared Jul 21, 1997

UNI-GRAFT K DV

K963790 · DSY

Atrium Medical Corp.

Cardiovascular · 304d