FDA 510(k) clearances — page 133
clearances on record, most recent first.
Clearances — page 133
13,201–13,300 of 176,479- K221759 — Cornisol
- K221892 — VISIONAIR
- K222515 — FaSet Fixation System
- K222737 — Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)
- K213464 — HemosIL Liquid Anti-Xa
- K220683 — INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)
- K221066 — Sterile Hypodermic Needles for Single Use
- K221068 — Sterile Hypodermic Syringes for Single Use with Needles
- K221073 — Sterile Hypodermic Syringes for Single Use with Safety Needles
- K221079 — Sterile Hypodermic Syringes for Single Use
- K221080 — Sterile Safety Hypodermic Needles for Single Use
- K221517 — POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens
- K221646 — CD HORIZON ASTUTE SPINAL SYSTEM +7 more
- K221928 — ROSA® Knee System
- K221994 — Hailie Sensor NF0107 & NF0108
- K222380 — TriVerse Total Knee Replacement System
- K222743 — Route 92 Medical Full Length 070 Access System
- K201237 — Velano Vascular Blood Collection Adapter
- K202953 — Aurolase Therapy, Laser Delivery Device (LDD)
- K212262 — PCA Syringe Sets
- K213014 — Varixis Elbow System
- K213842 — ONVOY Acetabular System
- K220220 — Electronic Sphygmomanometer (Model: LT-P30)
- K221047 — SILO TFX MIS Sacroiliac Joint Fixation System
- K221613 — Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets
- K221778 — Disposable Safety Lancets
- K222267 — Arthrex 2.4 mm Volar Distal Radius Plate System
- K222354 — Elastic Traction System
- K222376 — Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)
- K222937 — Disposable Nitrile Examination Glove
- K200073 — AugMENTA Penile Implant
- K210478 — 8mm Monopolar Curved Scissors
- K210567 — Ultrasonic Surgical System
- K211611 — QIR Suite
- K212316 — DoubleChek DC-1001
- K213023 — Blood Pressure Monitor(Model:Y30001)
- K213904 — Kerecis Oral
- K220336 — Mg-PSZ Ceramic Femoral Head
- K220366 — EmbedMed
- K220758 — e-Ortho Shoulder Software v1.1
- K221003 — Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA
- K221243 — OFNat Lubricant (L15)
- K221378 — Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile
- K222046 — Unscented Menstrual Tampon
- K222090 — Safety Lancet
- K222206 — Air Compression Leg Massager (Models: S9036C, S9036B and S9036A)
- K222244 — Arthrex 3.5 mm Locking Compression Plates
- K222339 — uDR 380i Pro
- K222625 — Shield System
- K222849 — AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector
- DEN200067 — INNOVANCE VWF Ac
- K213034 — SpineAR SNAP
- K213126 — Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws
- K213417 — Ghost Spacer System
- K213716 — InnovaBurn
- K220080 — CogNet QmTRIAGE
- K221300 — Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System
- K221375 — CureSight-CS100
- K221496 — Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System
- K221637 — Surgical Gown (Sterile); Surgical Gown (Non-sterile)
- K221918 — ReFlow System Mini
- K222005 — S.I.N. Instrument Kits
- K222353 — GM85
- K222383 — Anteralign LS Spinal System with Titan nanoLOCK Surface Technology MAZORX Stealth(TM) Edition
- K222605 — iFuse TORQ® Implant System
- K222687 — Digital Radiography CXDI-Elite, Digital Radiography E1
- K211902 — InnovaMatrix PD
- K212143 — Neteera 130H/131H Vital Sign Monitoring Sensor
- K220081 — CORE-SPORT
- K220245 — Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)
- K221397 — MitraClip G4 Steerable Guide Catheter
- K221548 — Dental Air Polishing Handpiece
- K221906 — TROJAN Fire & Ice lubricated male natural rubber latex condom
- K222316 — IPL Hair Removal Device
- K222328 — SteriCUBE® Multiple Tray Sterilization Systems
- K222329 — BriefCase
- K222442 — DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)
- K222482 — AGILON XO Shoulder System
- K222615 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
- K222627 — EndoGI S-Path Biliary Stent System
- K212561 — MTX-C1
- K213883 — NanoZoomer S360MD Slide scanner system
- K220342 — XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3
- K220785 — Clean Connecting Tube
- K220831 — Dental Implantation Systems, Dental Electrical Motors
- K221211 — Infrared thermometer
- K221360 — Medline UNITE® Medial Malleolus Peg Plate System
- K221738 — NS-HGlio
- K222648 — 5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W)
- K222661 — Digital Radiography CXDI-CS01
- K214015 — Palm NRG cellulite body device (model: Palm NRG body device)
- K220116 — Auryon Atherectomy Catheters
- K220795 — QT ECG
- K221062 — RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device
- K221473 — Flowart
- K221631 — Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V
- K222266 — Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)
- K222602 — Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R +1 more
- K222655 — OtoSight Middle Ear Scope
- K222629 — Resonic Rapid Acoustic Pulse Device
Data sourced from openFDA. This site is unofficial and independent of the FDA.