FDA 510(k) clearances — page 1448
clearances on record, most recent first.
Clearances — page 1448
144,701–144,800 of 175,890- K860161 — HEART CATHETERIZATION TRAY
- K860171 — VOROBA PROGRAMMABLE AUDITORY COMPARATOR
- K860204 — ANGIOMAT 6000
- K860508 — POSID SAMPLER
- K860526 — NOVA BALLOON THERMODILUTION PRESSURE TRANS CATH
- K860758 — VACO SUCTION ELECTRODE UNIT
- K860940 — MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT
- K860945 — DIRECTACLONE CG SLIDE PREGNANCY TEST
- K860950 — SCM-400 HOLTER SYSTEM
- K860981 — ASPIR-VAC DISPOSABLE SURGICAL DRAIN SYSTEM
- K860991 — SCLEROTHERAPY INJECTION CATHETER
- K860992 — VOX COMPANION
- K860997 — GASTROINTESTINAL CYTOLOGY BRUSH
- K861046 — MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA
- K861118 — ORTHOJOIN, ORTHODONTIC ADHESIVE
- K861140 — PROGRAMALITH III PULSE GENERATOR
- K861155 — EMIT DESIPRAMINE ASSAY
- K861164 — OSTEOMILL BONE GRINDER
- K861240 — BECHLER MEDICAL, MODEL 5000,THE WIZ HOLTER SCANNER
- K861260 — PEDABAROGRAPH
- K861307 — DISPOSABLE NEEDLE COUNTER
- K861308 — ACCUPAC CUSTOM PACK KERLIX SQUARES
- K861316 — DISPOSABLE NEEDLE COUNTER (20-240)
- K861317 — DISPOSABLE NEEDLE COUNTER (20-530)
- K861318 — DISPOSABLE NEEDLE COUNTER (20-720)
- K861319 — DISPOSABLE NEEDLE COUNTER (20-560)
- K861334 — CILCO DIAMOND KNIVES & DIAMOND KNIFE LINEAR GAUGE
- K861340 — R1750 AND R1424 POWERED HEATING UNITS
- K861346 — R1363 PARAFFIN
- K861347 — R1596 POWERED EXERCISE EQUIPMENT
- K861348 — R1361 & R1372 MEASURED EXERCISE EQUIPMENT
- K861350 — R1436,R1697,R1699,R1564,R1216,R1214,R854 & R1213
- K861352 — R1698,R1701,R1215,R1700 & R860 POWERED TABLES
- K861389 — PAP SMEAR KIT
- K861396 — HANDHELD DYNAMOMETER, MODEL #160 AND #111
- K861460 — SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101
- K861470 — #CTO 100 (CERVICAL TRACTION ORTHOSIS 100)
- K861474 — PB253 TO PB254 IR - SPECTROMETER UPGRADE KIT
- K861492 — HEARING AID (ALL IN THE EAR)
- K861540 — DISPOSABLE BERMAN AND GUEDEL AIRWAYS
- K861625 — SERVO GAS MONITOR 120
- K853988 — FORAN CORP-SURESERT INTRAVENOUS CATHETER PLACE UNI
- K854196 — DCI MODEL EP-2 CLINICAL STIMULATOR
- K854618 — CORDOT R
- K854705 — INFAGUARD TM
- K860479 — GREEN-LINE BIPOLAR COAGULATION UNIT
- K861010 — VMA BY HPLC TEST (VANILMANDELIC ACID)
- K861159 — SPECTRO VWF
- K861434 — MODIFIED HC-417 BAG TO BAG & HC-418 BOTTLE TO BAG
- K843247 — KOI PACHYMETER
- K854334 — PAINBLOCKER WA5000
- K860457 — ELECTROCARDIOGRAPH CONTINUOUS MONITOR
- K860470 — DEL MAR MODEL 750 INNOVATOR HOLTER MANAGEMENT SYST
- K860471 — DEL AMR MODEL 250 CARDIODISPLAY HOLTER SCANNER
- K860551 — ETP 180 CARDIAC PACEMAKER (EXTERNAL)
- K860676 — HEARTSTART 2000
- K860686 — FACEGLOV,ANESTHETIC GAS MASK
- K860811 — ZEISS VOICE CONTROL SYSTEM FOR OPMI'S
- K861083 — OSTEOGRAF/AR+(PLUS) ALVEOLAR RID HYDROX 18-40 MESH
- K861084 — OSTEOGRAF/AR ALVEOLAR RID HYDROX, 18-40 MESH
- K861148 — BISCO'S PORCELAIN VENEER SYSTEM
- K861196 — STERILE STOCKINETTE W/ANTIMICROBIAL AGENT
- K861265 — DIALET LANCING DEVICE
- K861329 — ISOTRAK AMYLASE ISOENZYME CONTROL SET
- K854637 — LEE ELECTRONICS PAL
- K855201 — BARD PARKER PERFUSION CATHETER
- K860362 — SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER
- K860523 — CARDIO-COOL
- K860539 — SARNS OXYGENATOR SYSTEM
- K860834 — SPACELABS MEDICAL WORKSTATION
- K860898 — SUBCLAVIAN INTRODUCER SET
- K860984 — TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT
- K861008 — PERCUTANEOUS CATHETERS
- K861176 — MODEL 366-20 ADAPTAID STEP-DOWN ADAPTER
- K861243 — NEONATAL UNILET
- K853401 — CHLAMYSET ANTIGEN
- K854370 — MPV-7201 NON-INVASIVE BLOOD PRESSURE MONITOR
- K860287 — PULSONIC DIGITAL BLOOD PRESSURE MONITOR MODEL BP-3
- K860824 — TSHK-NN RIA KIT
- K860841 — GUIDE WIRE INTRODUCER
- K860900 — IMMPULSE FREE ESTRIOL ASSAY REAGENTS
- K861025 — T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES
- K861104 — VARIABLE HIGH FLOW DOWNS CPAP GENERATOR
- K861203 — MULTI-SPIKE
- K861231 — ALT REAGENT CARTRIDGE (PRODUCT NO. 88210)
- K861283 — AST REAGENT CARTRIDGE
- K861284 — AP REAGENT CARTRIDGE
- K861333 — ULTRA-VIOLET GOGGLETS
- K861419 — HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE
- K861448 — QUANTIMETRIX SERUM LIPID CONTROL I & II LIQUID
- K860982 — DB PRECISION IMPLANT SYSTEM, 2000 SERIES
- K860993 — P.O. VOX
- K861005 — GLASIONOMER BASE CEMENT
- K861107 — TAN MATE HOME TANNING UNIT
- K861167 — IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST
- K861171 — QUIDEL ALLERGY SCREEN
- K861184 — PHADEBAS RAST/PHADEZYM RAST TEST ALLERGEN DISCS
- K861230 — MONITRAL S
- K861336 — IAP PLATE TEST
- K861405 — REPLACEMENT HOSES
Data sourced from openFDA. This site is unofficial and independent of the FDA.