FDA 510(k) clearances — page 510
clearances on record, most recent first.
Clearances — page 510
50,901–51,000 of 176,542- K101333 — CRYOCARE CS SURGICAL SYSTEM
- K101341 — POWDERED VINYL PATIENT EXAMINATION GLOVES
- K101444 — AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY
- K101529 — BD DIRECTIGEN EZ FLU A+B ASSAY
- K092987 — INRATIO/INRATIO2 TEST STRIPS
- K093118 — BRAINLAB KNEE ARTHROSCOPY
- K093340 — PASR/QUIETNITE
- K094022 — THE WATER LILY
- K100101 — GSP NEONATALGALT KIT, MODEL 3303-001U
- K100129 — AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X
- K100429 — URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER
- K100430 — URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER
- K100480 — ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH
- K100630 — G-FORCE PEEK SUTURE ANCHOR SYSTEM
- K100746 — FIBER ONE
- K100821 — PREVENA INCISION MANAGEMENT SYSTEM
- K101075 — ELECSYS INSULIN CALCHECK 5
- K101127 — PATIENT MONITOR, MODEL PM50
- K101242 — GENESIS DM MODEL: 6053000A1
- K101274 — VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM
- K101334 — JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON
- K101419 — ENSITE VELOCITY SYSTEM, MODEL EE3000
- K092731 — VIBRO-TRAC
- K093442 — GUIDED GROWTH SYSTEM
- K093679 — ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA0
- K093931 — BLOOD PRESSURE METER, MODEL CH-4532
- K100137 — SIDEKICK CIRCULAR FIXATOR SYSTEM: STRUTS AND HINGES
- K101044 — RETRIEVE IMPLANT CEMENT
- K101262 — FLEXI-LITE
- K093297 — EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE
- K093819 — ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER)
- K100398 — SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM
- K100623 — AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM
- K100711 — SUCTION IRRIGATION ELECTRODES AND ADAPTERS
- K100754 — GRAFT DELIVERY SYSTEM MODEL SA-6115
- K100772 — MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL)
- K092967 — PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE
- K093193 — LA GLOVE BRAND COLORED LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE (PINK/ GREEN/ VIOLET)
- K093729 — GUARDIVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 IN/ 4MM, STERILE, GUARD IVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 I
- K100217 — LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30
- K100509 — THL1 LASER
- K101002 — A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200
- K101008 — DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY
- K101445 — VITAL SIGNS MONITOR-VSM 6000 SERIES
- K091845 — CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM
- K092983 — PANPAC HSG CATHETER SET
- K100807 — MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191
- K100885 — FETAL MONITOR MODEL: BT-200T
- K101013 — MODIFICATION TO SCINTRON IV
- K093537 — HANAROSTENT ESOPHAGUS (CCC)
- K093853 — SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES
- K093975 — SIMPLER TOADSTOOL ABUTMENT, MODEL S19000-S19009
- K100545 — SLEEPRIGHT
- K100605 — MIS SYSTEM
- K100708 — PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES
- K101277 — ORION II (HEAVY DUTY 350 LBS AND 500 LBS)
- K091859 — AESKU PR3
- K092667 — GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT
- K093102 — AMBULATORY BLOOD PRESSURE MONITOR, MODELS FB-270 AND DS-270
- K093211 — CARECENTER MD
- K093630 — BIODENTA DENTAL IMPLANT SYSTEM
- K094056 — HOTDOG MULTI FUNCTION CONTROLLER
- K100546 — PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE
- K100775 — BD INTIMA II CLOSED IV CATHETER
- K100812 — ULTICARE DISPOSABLE PEN NEEDLES
- K100833 — SYLE SMARTIP
- K101030 — MODIFICATION TO HBS HEADLESS BONE SCREW
- K101297 — VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020
- K100175 — CLYDESDALE SPINAL SYSTEM
- K100563 — GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B130, MT-B132FA
- K100756 — MALTA
- K100905 — HYDROFIX SURGICAL SHEET
- K101221 — JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100
- K101239 — VIEWFLEX PLUS ICE CATHETER
- K091281 — TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA
- K100822 — XPERT MRSA/SA NASAL ASSAY
- K090386 — NON-INVASIVE INFRARED (NIR)
- K092117 — SCENAR, MODEL 10
- K092608 — SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX
- K092704 — ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03
- K092705 — ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501
- K093264 — VINYL EXAMINATION GLOVE, POWDER FREE, NON-COLORED
- K100151 — APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM)
- K100254 — REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER
- K100427 — FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY
- K100435 — AMEDA PLATINUM BREAST PUMP
- K100554 — RESPIRATORY HUMIDIFIER , HEATED DELIVERY SYSTEM, ADAPTOR, MODELS MR880, RT241, 900MR441
- K100606 — VATEA ENDONTIC IRRIGATION SYSTEM
- K100617 — MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20D
- K101275 — MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCH BP OFFICE AFIB (TWIN200 AFS).
- K090191 — HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB
- K091168 — GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025
- K092187 — MAIA, MODEL 1
- K093275 — EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER
- K093902 — MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573
- K100269 — NOVATION CROWN CUP GXL LINERS
- K100857 — FUSION MEDICAL RING LOCK SYSTEM
- K090379 — AVITA NASAL ASPIRATOR, MODEL, NS1 SERIES
- K093973 — TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
- K100637 — SYNGO.CT CORONARY ANALYSIS
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