FDA 510(k) clearances — page 1441
clearances on record, most recent first.
Clearances — page 1441
144,001–144,100 of 175,890- K861865 — ERIE-NEB
- K861878 — BYRON SUCTION TIPS
- K861897 — UNISKAN II
- K862007 — HCG IRMA, CAT. NO. CR-1501
- K862179 — SOMAS LIQUID URINE CONTROL
- K862186 — LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II
- K862210 — UREA NITROGEN (GLDH) REAGENT SET (UV)
- K862256 — ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET
- K862299 — AMRESCO FLOW PAC TOTAL BILIRUBIN REAGENTS
- K862331 — FUJITSU MALLEABLE - TIP BRAIN SPATULA
- K862375 — CARDIO PORT 500 24-H ECG AMBULATORY MONITOR SYSTEM
- K862415 — TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM
- K862416 — FTI 100 MEDICAL THERMAL IMAGER
- K853565 — ARTIS ULTRASOUND IMAGING SYSTEM
- K860579 — CARDIOSCAN DOPPLER OPTION
- K861207 — INTELLIJECT INFUSION PUMP
- K861208 — INTELLIJECT MEDICATION SYRINGE
- K861335 — STORZ COMPUSCAN 68K
- K861771 — META - HEALTH MODEL MTG III
- K862020 — HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER
- K862109 — ENZYMUN TEST TBG
- K862195 — RAPID BACTERIURIA SCREEN (RBS)
- K862216 — TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT)
- K860085 — LYOFOAM WOUND DRESSINGS
- K860664 — CRESOLPHTHALEIN COMPLEXONE, CALCIUM
- K861271 — SUCROSEP HUMAN PROLACTIN (HPR) IRMA
- K861361 — ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE
- K861387 — KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB)
- K861403 — TB SERIES BIPOLAR PACING LEADS
- K861580 — PROGROUP (TM) AUTOMATED LIQUID HANDLING SYSTEM
- K861635 — TRIGLYCERIDES GPO-TRINDER
- K861680 — OSTEONICS ELBOW PROSTHESIS
- K861775 — TWIN BUN/GLUCOSE
- K861793 — TWIN TRIGLYCERIDES GPO/CHOLESTEROL
- K861832 — RICH-MAR SPINA-MOBILIZOR
- K861926 — WORTHINGTON HDL PRECIPITATING REAGENT SET
- K861972 — DERMISTRIP
- K861998 — TOTAL BILIRUBIN TEST KIT
- K862002 — MEDISYSTEMS PHERESIS NEEDLE
- K862006 — STAND & HIGH FLOW FEMORAL-VENTRICULAR PIGTAIL CATH
- K862060 — POLYPECTOMY SNARE
- K862125 — ARIZONA CONDYLAR TIBIAL PLATEAU
- K862168 — RAICHEM CHOLINESTERASE REAGENT
- K862214 — EMIT QUINIDINE ASSAY
- K862218 — DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT
- K862249 — TSH IRMA KIT
- K853555 — FAST FORMALERT
- K860239 — ORG-7201 MULTIPARAMETER TELEMETRY MONITOR
- K860264 — SCHERER PORTABLE TOOTH POLISHER
- K860673 — OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B
- K860846 — CORDIS HI-FLEX PERVENOUS BIPOLAR LEAD
- K861422 — PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY
- K861428 — SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100
- K861502 — EOH 8501 OSSEOINTEGRATED IMPLANT SYSTEM
- K861846 — HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT
- K861956 — JELTRODE
- K862095 — MODEL CA, HEARING AID
- K862242 — PAP SMEAR KIT
- K854030 — WRIST ACTIGRAPH
- K860136 — BARD-PARKER CAROTID SHUNT
- K861274 — DOUBLE ANTIBODY CALCITONIN RIA KIT
- K861366 — ALT-30, 60 AND 100
- K861417 — ASSERA-PLATE VWF KIT
- K861475 — ASSERA-PLATE PROTEIN C KIT
- K861503 — COMPANION LIQUID OXYGEN SYSTEM
- K861671 — DIRECT BILIRUBIN PROCEDURE
- K861768 — THEOPHYLLINE (FPIA) CALIBRATOR KIT
- K861769 — GENTAMICIN (FPIA) CALIBRATOR KIT
- K861770 — PHENYTOIN (FPIA) CALIBRATOR KIT
- K861796 — FITTRONIC
- K861891 — TOBRAMYCIN (FPIA) CALIBRATOR KIT
- K861899 — SCOTCHBOND LIGHT CURED DENTAL ADHESIVE W/FLUORIDE
- K861963 — ULTRALITE HF1236 HAND AND FOOT SYSTEM
- K862114 — KHURI REGIONAL TISSUE PH MONITOR
- K862133 — HYGEIA RAPID STREP A TEST
- K862144 — X-MAT
- K862209 — ALT (SGPT) REAGENT SET (UV RATE)
- K854963 — S80 IMPLANTABLE CARDIAC PACING LEAD
- K862043 — DELFIA (TM) HFSH KIT
- K861040 — ENTERNAL INFUSER MULTIPUMP 203
- K861147 — UCS-2, ULTRASONIC CLEANING SOLUTION
- K861190 — PTT AUTOMATE TEST KIT
- K861209 — STREAM-SWITCH MANIFOLD
- K861388 — SARNS PORTABLE POWER MODULE
- K861487 — ST-90 SPIRO ANALIZER
- K861939 — MODEL PC HEARING AID
- K862021 — PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEM
- K862036 — MODEL HP HEARING AID
- K862050 — LIFESOUND CUSTOM ITE
- K862099 — DAHLBERG MODEL EE BEHIND-THE-EAR HEARING AID
- K862100 — MODEL ED BEHIND-THE-EAR HEARING AID
- K862101 — MODEL UM IN-THE-CANAL HEARING AID
- K862102 — MODEL KM IN-THE-CANAL HEARING AID
- K862103 — MODEL UC IN-THE-CANAL HEARING AID
- K862104 — MODEL UC SPECTRUM IN-THE-CANAL HEARING AID
- K862212 — LIFECARE REMOTE ALARM #34-001
- K862280 — SHOFU LINING CEMENT
- K862284 — SEALITE
- K854337 — SDL-300
- K854468 — PORTALASE 200 CARBON DIOXIDE SURG LASER NEUROLOGIC
Data sourced from openFDA. This site is unofficial and independent of the FDA.