FDA 510(k) clearances — page 1320
clearances on record, most recent first.
Clearances — page 1320
131,901–132,000 of 176,637- K892838 — IRON SYSTEM PACK REAGENTS
- K893117 — GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST
- K893125 — BECKMAN EPSILON(TM) IGE REAGENT KIT
- K893199 — PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR
- K893737 — DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST
- K884759 — SHOWER STRETCHER W/WHEELS
- K890171 — INLINE AUTOTRANSFUSION SYSTEM
- K890351 — ORTHORALIX SD/ORTHORALIX SD CEPH
- K890443 — CASPAR SCALP CLIP, APPLIER
- K890499 — BIVONA VENTILATOR ISOLATOR SYSTEM
- K890845 — PREMISE SERIES BED
- K890874 — BIOCHEM 520 BREATH INDICATOR
- K891180 — TRANSESOPHAGEAL ULTRASOUND ACCESSORIES KIT
- K891282 — MIC-100 WITH CRYOPROBES
- K891690 — KODAK EKTASCAN IMAGE MANAGER
- K891769 — MAGNISCAN 5000 MR SYSTEM
- K891990 — RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600
- K892052 — SARNS MEDICAL CART
- K892058 — ISL QC 2000
- K892516 — CANDELA PLDL-1 PULSED DYE LASER
- K892808 — KINETIC MODEL 700
- K892857 — HARVESTING TUBE
- K892866 — AUTOMATIC CRANIAL DRILL (PERFORATOR)
- K892877 — CRADLE, HOSPITAL BED CLOTHING
- K893707 — AUTO SUTURE SURGIPORT DEPTH GUIDE AND SKIRT
- K893709 — COHERENT MARIE ARGON PHOTOCOAGULATOR
- K890424 — ENTERAL FEEDING CONTAINER
- K891600 — ARGEDENT 88, DENTAL ALLOY FOR PORCELAIN)
- K892220 — LAMINARIA TENT
- K892264 — ORALCHEK SUPER-SOFT BRUSH
- K892456 — KULZER TRANSLUX EC
- K892624 — PATIENT EXAMINATION GLOVES (LATEX)
- K892625 — PATIENT EXAMINATION GLOVES (LATEX)
- K892768 — PATIENT EXAMINATION GLOVES (POLY)
- K892910 — ARGELITE 76SF+ DENTAL ALLOY
- K892923 — LATEX PATIENT EXAMINATION GLOVES
- K892945 — PATIENT EXAMINATION GLOVES
- K892961 — PATIENT EXAMINATION GLOVES
- K892965 — LATEX EXAM GLOVES (MFG. BROADLAND RUBBER INDUST.)
- K893047 — JASONTEX LATEX EXAMINATION GLOVES
- K893098 — VINYL EXAM GLOVES (MFG. TOPLAS INDUSTRIAL CO.)
- K893166 — LATEX EXAMINATION GLOVES
- K893266 — LATEX EXAMINATION GLOVES
- K893345 — ARGELITE 50 (DENTAL ALLOY FOR PORCELAIN APPLI.)
- K893381 — ARGENCO 71 TYPE II DENTAL GOLD ALLOY
- K893382 — ARGENCO 63 TYPE III DENTAL GOLD ALLOY
- K893383 — ARGENCO 75 TYPE III DENTAL GOLD ALLOY
- K893384 — ARGENCO 83 TYPE I DENTAL GOLD ALLOY
- K893385 — ARGENCO 77 TYPE II DENTAL GOLD ALLOY
- K893386 — ARGENCO 62 TYPE III DENTAL GOLD ALLOY
- K893413 — ARGENCO 40 TYPE III DENTAL GOLD ALLOY
- K893433 — PERSONAL AMPLIFIER MODEL ULTRA HELIX
- K893434 — ARGENCO 20 TYPE III DENTAL GOLD ALLOY
- K893441 — ARGENCO 50 TYPE III DENTAL GOLD ALLOY
- K893442 — ARGENCO 58 TYPE III DENTAL GOLD ALLOY
- K893443 — ARGENCO 60 TYPE III DENTAL GOLD ALLOY
- K893444 — ARGENCO 46 TYPE III DENTAL GOLD ALLOY
- K885091 — HEMAVIEW DARKFIELD MICROSCOPE SYSTEM
- K885211 — RF-100 MONITOR, RF-P-2.5, RF-P-5, RF-P-7.5 PROBES
- K885279 — CUTINOVA(R) PLUS ON VASCULAR STASIS ULCERS
- K890814 — DANEK RING FIXATOR (DRF)
- K891680 — LYPHOCHEK TUMOR MARKER CONTROLS, LEVELS I AND II
- K891906 — ROBICSEK INTRACARDIAC SUCTION WAND
- K892205 — DANAM VECTOR-8+
- K892645 — AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY
- K892802 — SUPER DUO
- K892928 — HAEMOPHILUS TEST MEDIUM (AGAR)
- K893439 — HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C
- K893530 — IRISTAIN FORMULA 2, PARTS 1 AND 2
- K893663 — INSTANT EOSIN-AQUEOUS
- K881979 — RESUBMITTAL OF MI 1000C MICROIMAGER
- K884250 — RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.)
- K884793 — ADVENT VENTILATOR
- K884910 — MODEL 1010, CY-MET
- K890010 — CM 7000MR
- K890072 — PRIMROSE FEMALE EXT. CATH OR EXT. URINARY DRAINAGE
- K890198 — PARAMED MODEL 9350 BLOOD PRESSURE MONITOR (9350)
- K890355 — DENTAL X-RAY BITE BLOCK
- K890637 — EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE
- K890800 — ROTATING HEMOSTATIC VALVE
- K890932 — CAV 3.0C SOFTWARE PROGRAM
- K891408 — MODIFIED PROFILE HIP ACETABULAR PROSTHESIS
- K891595 — MODEL 116 FETAL MONITOR
- K891611 — MODELS 6526,6527,6528 PERCU. TRANS. ANGIO. CATH.
- K891612 — DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA.
- K892002 — NEOCHROME(R) III GLUCOSE
- K892207 — FRANZ(TM) MOVEABLE STYLET MAP CATHETER, MODIFIED
- K892373 — DENTAL PLASTIC BITE FORK
- K892432 — KENDALL CURITY ENDOTRACHEAL TUBES
- K892435 — KENDALL CURITY OXYGEN NASAL CANNULA
- K892529 — REPRO-MED NEONATE ASPIRATION SYSTEM
- K892704 — GEM II ORTHODONTIC BRACKET
- K892811 — ARGELITE 54B
- K893035 — OPHTHASCAN 'S' MINI-A
- K893037 — NO-MIX 30 ORTHODONTIC BONDING SYSTEMS
- K893227 — ARGENCO W+
- K893428 — ALPHA SHOPPER
- K893429 — ALPHA CONDOR
- K893490 — HANDI-LIFT/VICTORY WHEELCHAIR LIFT
- K893503 — SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS
Data sourced from openFDA. This site is unofficial and independent of the FDA.