FDA 510(k) clearances — page 542
clearances on record, most recent first.
Clearances — page 542
54,101–54,200 of 175,825- K090173 — NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
- K080779 — IRRISEPT WOUND CLEANSING SYSTEM
- K080910 — PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS
- K081372 — GELX ORAL GEL
- K081495 — CELL-DYN EMERALD SYSTEM
- K081947 — GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING
- K082082 — GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING
- K082150 — MODIFICATION TO PAXGENE BLOOD RNA SYSTEM
- K082691 — POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K083034 — FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F
- K083153 — ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007
- K083300 — GORE FLOW REVERSAL SYSTEM
- K083523 — MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE
- K083781 — EEA HEMORRHOID STAPLER & ACCESSORIES
- K083898 — SURGIMEND
- K090170 — SPYSCOPE ACCESS AND DELIVERY CATHETER
- K081576 — BLAZER DX-20 DIAGNOSTIC CATHETER
- K082162 — COULTER BODY FLUID CONTROL
- K082400 — DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS
- K082407 — MODIFICATION TO ULTRALIGHT II ND: YAG LASER SYSTEM
- K083002 — SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER
- K083127 — ASAHI CORSAIR MICROCATHETER
- K083200 — X-CAL
- K083221 — AIDERA DIASEND
- K083265 — JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381
- K083269 — CROSSOVER
- K083287 — AVIVO MOBILE PATIENT MANAGEMENT SYSTEM
- K083420 — MEDONIC M SERIES
- K083621 — MEDPOR CUSTOMIZED SURGICAL IMPLANT
- K080708 — VISION HOLLOW FIBER OXYGENATOR WITH HA COATING
- K081556 — CADSTREAM, VERSION 5.0
- K082262 — LDR SPINE ROI INTERBODY FUSION SYSTEM
- K083067 — MS SYSTEM
- K083152 — EQUASHIELD SYSTEM
- K083313 — WILDCAT 7F GUIDEWIRE SUPPORT CATHETER
- K083338 — CARDIFF ANTERIOR CERVICAL PLATE SYSTEM
- K083373 — IMMULITE 2000 FREE T4
- K083544 — KAT IMPLANT SYSTEM
- K083667 — NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337
- K083711 — MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34
- K083748 — IPULSE, MODEL: I150
- K083918 — ATL CO2 MEDICAL LASER SYSTEMS, MODELS ATL-150 AND ATL-250
- K090027 — BLOOD PRESSURE MONITOR, ZSBP-003/004/005/006/007/008 AND ZSBP-102/103/104/105/106/107
- K090091 — OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM
- K080117 — PATIENT ISOLATION UNIT, MODEL G019-1000
- K080513 — QLASER SYSTEM
- K080782 — NITI-S ESOPHAGEAL STENT
- K081153 — NOVEL SPINAL SYSTEM
- K082482 — FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4251/TD-4252A/TD-4252B/TD-4254
- K082866 — REVOLUTIONFULL FACE MASK
- K083040 — S-TEST C-REACTIVE PROTEIN (CRP)
- K083059 — AIR SONIC SCALER
- K083226 — SMITH & NEPHEW PEEK INTERFERENCE SCREW
- K083258 — MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE
- K083286 — ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEM
- K083464 — PREMIER CAMPY, MODEL 618096
- K083496 — CAMLOG IMPLANT SYSTEM MODIFIED IMPLANTS AND ABUTMENTS
- K083635 — SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW
- K083717 — POWDER FREE NITRILE EXAMINATION GLOVES, BUBBLE GUM SCENTED, PINK
- K083771 — RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP
- K083847 — MARVEL PEDIATRIC WHEELCHAIR
- K083882 — MYLABFIVE
- K090023 — IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E
- K090096 — ALL-IN-ONE CONTAINER
- K090098 — MAXIM HYGIENE ORGANICALLY GROWN COTTON TAMPON
- K073593 — I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016
- K081548 — ANTERIOR BUTTRESS PLATE
- K082035 — MAICO MB 11 WITH BERAPHONE PROBE
- K082852 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN (GP) 4-128 UG/ML
- K082973 — STER-MATE STERILE LAVAGE KIT
- K083246 — FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5961
- K083247 — FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7906
- K083248 — FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7902
- K083317 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5902
- K083318 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5904
- K083319 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7941
- K083574 — RELIEVA STRATUS MICROFLOW SPACER
- K083904 — ASAHI SUOH PTCA GUIDE WIRE
- K083915 — ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC
- K081846 — GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951
- K083279 — CALTRIX RESORBABLE BONE VOID FILLER
- K083297 — PITT-EASY DENTAL IMPLANT SYSTEM
- K083323 — NUVO VERDE LED LIGHTING SYSTEM
- K083528 — SMITH & NEPHEW BIPOLAR ADAPTER CABLE, MODEL 72200022
- K083618 — PACS SCAN
- K083865 — PILOT SPINAL SYSTEM
- K090009 — THD SLIDE ONE
- K090045 — COLOR LCD MONITOR, RADIFORCE RX320
- K081787 — CAMLAB CRANIAL ORTHOSIS HELMET
- K081878 — LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM
- K082504 — APOLLO ANTERIOR CERVICAL PLATE SYSTEM
- K082754 — AEQUALIS HUMERAL NAIL SYSTEM
- K082799 — HDS HI 1.54
- K083209 — ACRYLIC HERBST SPLINT APPLIANCE
- K083337 — NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES
- K083617 — APIERON INSIGHT ENO SYSTEM
- K081838 — GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING
- K083159 — BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2
- K083175 — BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2
- K083201 — ZMATCH BLOCK
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