FDA 510(k) clearances — page 1360
clearances on record, most recent first.
Clearances — page 1360
135,901–136,000 of 175,890- K880880 — RAICHEM(TM) MAGNESIUM REAGENT, ENZYMATIC
- K880917 — LYTENING 5
- K881005 — IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG
- K881214 — IMMPULSE T, ASSAY REAGENTS
- K881229 — AUTO TROL(TM) CONTROL, LEVELS 1 & 2 #16692 & 16693
- K881241 — TOTAL BILIRUBIN REAGENT
- K881257 — EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT
- K881258 — PARAMAX ALCOHOL AND AMMONIA CALIBRATOR, I & II
- K881326 — HDL CHOLESTEROL PRECIPITATING PROCEDURE
- K881337 — EMDS LIDOCAINE CALIBRATOR ITEM NO. 67XXX/95
- K881357 — EMIT CONVENIENCE PACK: THYROXINE ASSAY
- K881373 — AMERLITE TT3 ASSAY, LAN.0003/2003 240/144 KIT
- K881435 — PREGNOSPIA II
- K881440 — IQ POTASSIUM
- K881443 — LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY
- K881595 — QUIDEL PREGNANCY TEST
- K881596 — FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057
- K881626 — GAMMA-GLUTAMYL TRANSFERASE
- K881655 — SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL
- K881702 — BIOTROL TRIGLYCERIDES ENZYMATIQUE UV H.P.
- K881858 — ACE ICPM SIDE PORTED NEEDLE
- K880102 — BIASOL CONCENTRATES FOR BICARBONATE DIALYSIS
- K880605 — LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER
- K880801 — SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9
- K880802 — SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11
- K880850 — KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVE
- K880860 — CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015
- K880943 — MICROLINE CAT #100
- K881027 — MSI 2002 SERIES BED
- K881052 — CHECK VALVE
- K881283 — MEADOX INTRA-AORTIC GRAFT
- K881711 — VICOR MODELS 410B & 410D AND MODIFIED 410A PACEMA.
- K881909 — TOSHIBA DIGITAL CLINICAL THERMOMETER
- K882090 — HIP SAVER
- K882091 — STAIR VEYOR
- K874465 — SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD
- K875178 — MODEL 435-04 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD
- K875337 — HEPARIN COATED LUMINAL PACING CATHETER
- K880231 — MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER
- K880929 — NIDEK CV-4000
- K880991 — LASER OPTICAL CATHETER SYSTEM
- K881184 — INTERTECH STERILE WATER FOR INHALATION
- K881278 — SPECTACLE, FRAME AND SUNGLASSES
- K881327 — STUART CANNULATED CANCELLOUS BONE FIXATION SCREW
- K881419 — PLASTIC FRAME & LENS SUNGLASS
- K881491 — MODEL 3487A PISCES EPIDURAL LEAD
- K881508 — OCHSNER & MICRON FABRIC PATCH
- K881594 — SUNGLASSES
- K881712 — MEDTRONIC MODEL 5866-36 LEAD ADAPTOR KIT
- K881882 — SENOGRAPHE 600T AND 600TS SENIX HF
- K881922 — CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE
- K881927 — PRISMA TECH 19 GAUGE DISPOSABLE EXTRUSION NEEDLES
- K881949 — ATS NAC-PAC SET
- K863395 — WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER
- K875100 — MODEL 438-03 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD
- K880763 — NEZHAT IRRIGATION PUMP SYSTEM
- K880777 — 8.5 FR. PESCUTANEOUS SHEATH INTRODUCER SYSTEM
- K880887 — NEOCATH
- K881006 — STOCKERT-SHILEY BUBBLE MONITOR 23-23-01
- K881824 — LASER MICROMANIPULATOR
- K881870 — SHARPLAN ND:YAG SURGICAL HAND APPLICATORS
- K875170 — EBNA ANTIBODY
- K875366 — THE DDI SERODOT HERPES IGG TEST KIT
- K880144 — STANBIO SYPHILIS RPR TEST, NO. 1170
- K880469 — CHLAMYDIAZYME(TM)
- K880499 — HEMOCCULT SENSITIVE TEST
- K881312 — LAMINARIA
- K881515 — TEAR VOLUME TESTS
- K881590 — ADFUSE(TM)
- K882012 — LIFESTYLE SOF. CARE GEL CHAIR CUSHION
- K871442 — BIOSOUND MMI ULTRASOUND
- K874377 — ANATOMIC ADJUSTABLE AXIAL FIXATOR ASSEMBLY
- K874505 — CONTAIN(TM)
- K874850 — EPI-SCAN SELECTIVE TISSUE CONDUCTANCE METER
- K875332 — IVAC VOLUMETRIC PUMP - MODEL 590
- K880306 — EMERGENCY-CLEAN UP(TM) ECP
- K880506 — MODIFIED EVA-MIX AND DI-MIX BAGS
- K880720 — MONTGOMERY NERVE STIMULATOR
- K880871 — GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER
- K880876 — C-STAT/1000
- K881310 — DENT SLEEVE MANOMETRIC CATHETER
- K881493 — PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF.
- K881690 — PORT-A-CATH PORTAL INTRODUCER FORCEPS
- K881956 — NATIONAL-STANDARD NEEDLE HOLDER
- K881957 — HAWKINS-AKINS BLUNT NEEDLE ACCESS KIT
- K881313 — IQK-200
- K881356 — EXTERNAL PACEMAKER WIRE DRESSING CHANGE
- K881951 — RIDE-LITE 9000 SERIES WHEELCHAIR
- K874396 — OCO PREPARATIONS
- K875036 — INTRA-AORTIC BALLOON PUMP MODEL KAAT
- K875370 — SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TX
- K880167 — GORE-TEX VASCULAR GRAFT
- K880774 — SPECTRUM
- K881003 — DIGITAL BLOOD PRESSURE MONITOR MODEL CX-1
- K881136 — HEWLETT-PACKARD MODELS 78354A & 78352A PULSE OXI.
- K881143 — IMPULSE TVC (RICHARDS, OMNI, MARCON)
- K881193 — ACCUTONE IN-THE-EAR HEARING AID
- K881279 — EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET
- K881281 — COAG-A-MATE(R) XM
- K881328 — MODEL 375 ECG
Data sourced from openFDA. This site is unofficial and independent of the FDA.