FDA 510(k) clearances — page 712
clearances on record, most recent first.
Clearances — page 712
71,101–71,200 of 175,825- K031652 — VASCUPUNCTURE PICC GUIDEWIRE
- K032076 — SENOVA(R) BLOOD GLUCOSE MONITOR
- K032116 — TULIP COLORSWITCH
- K032161 — PHEM-ALERT
- K032247 — U.S. TECHNOLOGIES, INC. RETRACTABLE SAFETY SYRINGE
- K032316 — ORION E ALLOY
- K032317 — ORION GX ALLOY
- K032318 — MINERVA 58 ALLOY
- K032319 — CERA R PLUS ALLOY
- K032321 — CERA F ALLOY
- K032693 — DURAGEN PLUS DURAL GRAFT MATRIX
- K032701 — SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33)
- K032875 — ALOKA MODEL SSD-5500 V6.0 ULTRASOUND SYSTEM
- K022490 — KSEA MEDI PACK
- K023103 — DEPUY 1 GENTAMICIN BONE CEMENT
- K023626 — AML HAIRCHECK-DT (COCAINE)
- K023778 — DRESSSKIN
- K030003 — ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR
- K030050 — TORAYSULFONE DIALYZER, BS-L SERIES
- K030803 — PARAPAC 200D TRANSPORT, MODEL V200D
- K031031 — VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS
- K031225 — TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004
- K031960 — INTRALASE FS LASER
- K031974 — ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0
- K032042 — ENVISION
- K032232 — AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE
- K032240 — BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT
- K032275 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-IMIPENEM 1-16 UG/ML GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS
- K024076 — MAKY 21.1 DIALYZER REPROCESSING SYSTEM
- K030014 — ATAC TOTAL BILIRUBIN REAGENT
- K031308 — RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760
- K032151 — DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS
- K032342 — COULTER LH 750 HEMATOLOGY ANALYZER
- K032680 — SMITH & NEPHEW 300XL XENON LIGHT SOURCE-HERMES READY MODEL, 7210045
- K032684 — RAYCELL
- K032715 — DW 296 #15 SOLDER
- K032832 — IRRIGATION SETS
- K032838 — CELON ENT SYSTEM
- K032847 — EXCISOR BIOPTOME, MODEL 01-0004
- K032851 — ULTRACROWN 75 ALLOY
- K032892 — MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEM
- K030393 — OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER
- K031485 — RINSPIRATION SYSTEM
- K032025 — SENTINOL NITINOL BILLARY STENT SYSTEM
- K032030 — BLINK CL LUBRICANT EYE DROPS
- K032176 — RATTAN IMACS BY RATTAN INFORMATION CORPORATION
- K032248 — PRECISE CARBON FIBER TABLE TOP, MODEL 11-999
- K032355 — ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW
- K032497 — SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT
- K032550 — EXOMIO, MODEL 2.0 SP1
- K032591 — NUMED TYSHAK MINI PEDIATRIC PTV CATHETER
- K032633 — HRK-63-8 KNEE ARRAY COIL
- K030187 — REPROCESSED ELECTROPHYSIOLOGY CATHETER
- K031356 — HEMAPROMPT GASTRIC
- K031360 — GI SUPPLY BILIARY STENT
- K031898 — EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM
- K031971 — GLOBAL CAP RESURFACING REPLACEMENT SHOULDER
- K032157 — TELEMIS-MEDICAL SOLUTION
- K032277 — JUSTWIN SCOOTER, MODEL JS-401
- K032402 — RODEO MODEL, RD12, RD14, RD16, RADIO TRANSIT MODEL, RD12T, RD14T, RD16T,
- K032489 — WU'S 4-WHEELED NEO SCOOTER, WT-M4JR
- K032505 — AIR PRESS MASSAGER
- K032635 — DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300
- K032678 — MODIFICATION TO: AURORA
- K032681 — KONICA LASER IMAGER, MODEL DRYPRO MODEL 771
- K032780 — INVIRO SNAP SAFETY SYRINGE, 1CC, 3CC, 5CC, AND 10CC
- K023429 — ROWENTA INC. BODYPARTNER VISION, MODEL BM 210 (2079565620)
- K030902 — PALACOS R
- K030903 — OSTEOPAL
- K030904 — PALAMED
- K030966 — CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER
- K031214 — CYCLONE ANTERIOR CERVICAL PLATE SYSTEM
- K031305 — OLYMPUS ULTRASONIC SURGICAL SYSTEM
- K031449 — MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION
- K031531 — S&T MICROSURGICAL SUTURE
- K031669 — STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER COATING
- K031670 — STERILE POWDER FREE LATEX SURGICAL GLOVE WITH POLYMER COATING
- K031895 — KSEA OPSERVER LAP
- K031897 — PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER
- K031944 — VINYL EXAMINATION GLOVES, POWDER FREE AND PINK COLOR
- K032242 — PERSONNA PLUS SAFETY SCALPEL SYSTEM
- K032364 — MICROLIFE DIGITAL UNDERARM ELECTRONIC THERMOMETER, MODEL MT 18E1 (V932)
- K032440 — F-11 FOLDING POWER CHAIR
- K032468 — SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE
- K032553 — TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
- K032606 — OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6 PSOTERIOR-STABILIZING, CEMENTED FEMORAL COMPONENTS
- K032642 — BEELINE SYSTEM
- K032707 — CONTOUR SE MICROSPHERES (SYRINGE)
- K032709 — MODULAR PLUS HIP STEM
- K032769 — EYESOPEN TONOMETER
- K032771 — MEDRAD CONTINUUM MR INFUSION SYSTEM
- K032773 — DIAMOND D HIGH IMPACT DENTURE ACRYLIC
- K032833 — MYOSYSTEM WITH CUSTOMIZING
- K023983 — MODIFICATION TO HIGHGATE CURVED ROD SYSTEM
- K024125 — HALM ZIELKE INSTRUMENTATION SYSTEM
- K030867 — ESKA MODULAR HIP SYSTEM CEMENTED
- K031280 — ULTRA-DRIVE 3
- K031604 — GLYCOMARK
- K031889 — ALEXIS WOUND RETRACTOR
- K031945 — ARTHREX TRIMIT SCREW, MODEL AR-4161B
Data sourced from openFDA. This site is unofficial and independent of the FDA.