FDA 510(k) clearances — page 392
clearances on record, most recent first.
Clearances — page 392
39,101–39,200 of 175,770- K133684 — ULTRABLOX
- K130087 — PANPAC WORD/BARTHOLIN CATHETER
- K130168 — CL10009 IR LASER
- K130235 — SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY
- K130662 — ET PROSTHETIC SYSTEM
- K132071 — BIOACTIVE BONE GRAFT PUTTY
- K132076 — REAGENT, RUSSEL VIPER VENOM - LA CONFIRM
- K132130 — REAGENT, RUSSEL VIPER VENOM - LA SCREEN
- K132210 — FUJIFILM 600 SERIES ENDOSCOPES
- K132335 — ULTRASOUND SCANNER FLEX FOCUS 1202
- K132346 — ULTRASOUND SCANNER PRO FOCUS 2202
- K132403 — ANNEXTM ADJACENT LEVEL SYSTEM
- K132660 — NERVE CUFF
- K132731 — DIGIFIX EXTERNAL FIXATION SYSTEM
- K133191 — PROBEAM PROTON THERAPY SYSTEM
- K133302 — FLEXMAP 3D
- K133310 — AXIUM DETACHABLE COIL SYSTEM
- K133604 — ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS
- K121235 — LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM
- K122982 — CRYOLOCK
- K123986 — ACTIM PROM
- K130851 — CASCADE HEMODIALYSIS/APHERESIS CATHETER
- K130888 — SONOPULSE/ SONOPULSE III
- K131554 — RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT
- K131958 — BAUSCH & LOMB INJECTOR SYSTEM
- K132729 — ISO-GARD MASK
- K132834 — FASTEP S10 HCG SERUM/URINE COMBO TEST
- K133244 — TAMPAX M PLASTIC TAMPONS, UNSCENTED
- K133256 — ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM
- K133261 — MEDOS HILITE 7000 & 7000 LT OXYGENATOR
- K133286 — MIDLINE (TM)
- K133321 — ALAMO C
- K133371 — RAMPART-L
- K133520 — HAMMERLOCK 2
- K130476 — ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGE
- K130681 — ENDOVASCULAR LASER VENOUS SYSTEM KIT WITH 2 RING RADIAL EMITTING FIBER
- K130843 — SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE
- K131000 — V-PATCH SYSTEM
- K132247 — ULTRASONIC MESH NEBULIZER
- K132843 — VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)
- K132880 — MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE
- K133049 — 3I T3(R) EXTERNAL HEX DENTAL IMPLANTS
- K133452 — EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM
- K133747 — ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM
- K133750 — OCCLUDER OCCLUSION BALLOON CATHETER
- K133762 — ENDO GIA(TM) EXTRA LONG ADAPTER
- K124033 — MEDISISS REPROCESSED ULTRASONIC INSTRUMENTS
- K130122 — BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER
- K131832 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K132296 — D-RAD SMART PACK
- K132581 — MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGE
- K132677 — ULTRASOUND SCANNER FLEX FOCUS 1202
- K132735 — AXIA RADIAL HEAD SYSTEM
- K133167 — MONOPOLAR CAUTERY CORD, BIPOLAR CAUTERY CORD
- K133413 — IDSS SLC
- K133736 — ENDOSCOPIC SUTURE CUTTER
- K123262 — OPTIFLUX ULTRA DIALYZER
- K131276 — LATERAL SYNFIX
- K131461 — LIGHTSTIM FOR ACNE/ LIGHTSTIM FOR ACNE MINI
- K131469 — ACON ON CALL DIABETES MANAGEMENT SOFTWARE
- K132439 — SAKURA STEAM STERILIZER ASSR; -AO12, -A012W, -AO12P,-AO12PW / SKYTRON INTEGRITY 270;STEAM STERILIZER,VP STEAM STERILIZER
- K132685 — ULTRASOUND SCANNER PRO FOCUS 2202
- K132769 — ACUMED HAND PLATING SYSTEM
- K132830 — DISTALOCK TIBIAL IM NAIL SYSTEM
- K133686 — 21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2 (ML21035)
- K133826 — INTONEMV
- K130606 — FMWAND FERROMAGNETIC SURGICAL SYSTEM
- K130937 — WAVE 2G, SOUL
- K130998 — SYNGO.VIA WEB VIEWER
- K131272 — SIREN EPCR SUITE
- K131516 — PRISMAFLEX SYSTEM 7.10
- K131880 — SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM
- K132399 — ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL
- K132733 — ORTHOHELIX SYNDESMOSIS FIXATION DEVICES
- K132923 — FUSION SINGLE LINK
- K133146 — BAUSCH + LUMB, VIS100 INJECTOR SYSTEM
- K133224 — Y-KNOT RC ALL-SUTURE ANCHOR, 2.8MM - DOUBLE LOADED AND TRIPLE LOADED W/ #2 HIFI SUTURES
- K133312 — EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
- K133645 — PERIMETER C SPINAL SYSTEM, CAPSTONE SPINAL SYSTEM, CAPSTONE L SPINAL SYSTEM, PERIMETER SPINAL SYSTEM
- K133714 — TRU FLU
- K130670 — HYDROFERA BLUE PU BACTERIOSTATIC DRESSING
- K130901 — SOMATOM DEFINITION AS OPEN
- K131364 — FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE
- K132661 — LIGHTSCALPEL
- K132969 — SPEC MODEL M15
- K133393 — GELPOINT PATH TRANSANAL ACCESS PLATFORM
- K133512 — LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)
- K131053 — ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM
- K132520 — NASAL EASE ALLERGY BLOCKER
- K132629 — REPROCESSED DILATING TIP TROCARS
- K133026 — UNBALLOON NON-OCCLUSION MODELING CATHETER
- K133081 — TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL N
- K133806 — M1 CAPNOGRAPHY MASK
- K132308 — CLIQ DV-300 ASPIRATOR
- K132559 — MONUMENT SPACERS
- K132747 — VISUM BLADE LED SURGICAL LIGHTING SYSTEM
- K132867 — SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 2.2MM
- K132875 — COMPRESSYN STAPLE
- K133490 — G-SCAN BRIO
- K130895 — REUNION RSA SHOULDER SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.