FDA 510(k) clearances — page 972
clearances on record, most recent first.
Clearances — page 972
97,101–97,200 of 176,637- K963487 — DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENS
- K963598 — INNOVATIVE TECHNOLOGIES ALIGINATE/PECTIN WOUND DRESSINGS
- K963603 — DERMAGRAN HYDROPHILIC OINTMENT
- K963610 — AKI COMPACS DATA COMPRESION MODULE FOR DIAGNOSTIC IMAGES
- K963655 — CD HORIZON ANTERIOR SPINAL SYSTEM
- K963694 — EASYLYTE CALCIUM/CHLORIDE ANALYZER
- K963697 — ADVANCED DIAGNOSTIC VIEWER (ADV)
- K963714 — GRAND MEDICAL SUTURE REMOVAL KIT
- K963715 — DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY
- K963719 — CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY
- K963720 — TRACHEOSTOMY KIT
- K963721 — SKIN SCRUB TRAY
- K963722 — IV START KIT
- K963723 — LACERATION TRAY
- K963735 — COJET SYSTEM
- K963788 — PRIMOFOCUS COMPACT
- K963798 — SYNTHES TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEM
- K963805 — PRODIGY AC
- K963875 — AHS OMEGA K-AMP
- K963941 — THE PHARAOH COMPENSATING FILTER
- K963999 — AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE
- K964094 — MINIFIX
- K964109 — MICROSURGE LAPAROSCOPIC PERMACLIP CARTRIDGE WITH IMPLANTABLE CLIP
- K964144 — PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - PCP-MF
- K964214 — STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS
- K964244 — STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS
- K964308 — VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)
- K964310 — VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010)
- K964349 — AIA-PACK FOLATE ASSAY
- K964451 — PICCOLO K-AMP VC+, PICCOLO P-A1, PICCOLO P-AO AND PICCOLO ATC
- K964502 — UNITRON MODEL SOUND F/XP +4
- K964503 — UNITRON MODEL SOUND F/X +4
- K964504 — UNITRON MODEL ICON AOHPL +4
- K964508 — UNITRON MODEL ICON AOHP +4 (ICON AOHP +4)
- K964510 — UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4)
- K964511 — UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4)
- K964530 — DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT
- K964557 — RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION
- K953252 — DISPOSABLE SCALP VEIN INFUSION SET
- K955756 — KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR
- K961656 — TEST-MATE CHE CHOLINESTERASE TEST SYSTEM
- K962045 — ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT
- K962205 — STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE
- K962623 — OSMOCYTE ULTRA/PE PILLOW WOUND DRESSING
- K962631 — DEXIS MODEL 601 DENTAL ELECTRONIC IMAGING SYSTEM
- K962816 — SPERM PREPARATION MEDIA
- K963183 — BIOZ SYSTEM
- K963189 — ERBE APC 300 ARGON PLASMA COAGULATOR AND ACCESSORIES - ARGON PLASMA COAGULATOR AND ACCESSORIES
- K963389 — FLEX-LASE 600 SERIES ION LASER SYSTEM
- K963400 — NELLCOR SYMPHONY N-3000 PATIENT MONITOR WITH SPO2 AND ECG AND N-3200 DISPLAY/PRINTER
- K963496 — OXI TEMP
- K963510 — APREMA I - ALTERNATING PRESSURE AIR FLOTATION MATTRESS SYSTEM
- K963626 — 9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS
- K963648 — STRYKER SUCTION REGULATOR
- K963677 — 9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD
- K963704 — MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE
- K963745 — MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR)
- K963757 — IRRIGATION/SUCTION HANDLE AND SHEATH
- K963838 — STARKEY TM AIR CONDUCTION TINNITUS MASKER
- K963873 — AHS OMEGA DEQ
- K963874 — AHS OMEGA AGC
- K963876 — AHS OMEGA PP
- K963879 — AHS DELTA 22
- K963881 — AHS DELTA 22 T
- K963995 — STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER
- K964180 — AUDIO 'D' SOUND SELECTOR POWER (SSP)
- K964312 — MENTOR TONO-PEN 3
- K964464 — PACIFIC 52 (CB-39)
- K964465 — LA PLATA 34 (PM-25)
- K964478 — OSAGE 76
- K960615 — GAUZE COMPRESS
- K961738 — VIT COMMANDER SYSTEM
- K962015 — RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST
- K962019 — C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST
- K962157 — MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM
- K962252 — HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4
- K962341 — HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG)
- K962450 — HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE
- K962451 — HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO)
- K962452 — HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA
- K962568 — ACRI ILIAC CREST ASPIRATION BIOPSY NEEDLES
- K963397 — ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER
- K963415 — VENTREX OXYGEN SENSOR
- K963434 — VISCOUS FLUID SYSTEM
- K963686 — ANSPACH SUTURE ANCHOR (MODIFIED)
- K963768 — INSTANT HOT PACKS
- K963783 — MITEK ELECTROSURGICAL SYSTEM FOR ARTHROSCOPIC USE
- K963954 — CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY
- K964011 — SUCTION CATHETER TRAY PRODUCT NO. 900277
- K964058 — SPENSER SUNGLASSES AND SPORT SUNGLASSES
- K964082 — SUNGLASSES
- K964087 — BLOCK STOP WIRES
- K964155 — CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST
- K964156 — CONTRAST STRIP HCG
- K964213 — TRACE RITE SOLID GEL ECG ELECTRODES
- K964413 — SUNGLASSES(NON-PRESCRIPTION)
- K964422 — ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL
- K955749 — TEX-CARE STERILE STOCKINETTE
- K963211 — UNISEAL GLOVES (LOW PROTEIN,POWDER FREE)
- K963260 — DRESSING CHANGE TRAYS
Data sourced from openFDA. This site is unofficial and independent of the FDA.