FDA 510(k) clearances — page 965
clearances on record, most recent first.
Clearances — page 965
96,401–96,500 of 175,890- 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
- K963356 — PHASED ARRAY SHOULDER COIL
- K963363 — HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS
- K963410 — POSEY STRAIGHT JACKETS
- K963414 — MULTIPLE BELTS
- K963421 — PROTECTIVE RESTRAINT (WAIST HOLDER)
- K963422 — PROTECTIVE RESTRAINT (PROTECTIVE MITT)
- K963430 — PROTECTIVE RESTRAINT (VEST RESTRAINT)
- K963436 — RESTRAINT ACCESSORIES
- K963442 — JACKETS AND VESTS
- K963485 — SILICONE RUBBER CUFF/DISPOSABLE FLEECE LINER'S WEB TORSO RESRAINT,NYON LIMB HOLDER,VINYL LIMB HOLDER,NYLON BED RESTRAINS
- K963552 — QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350)
- K963559 — WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010)
- K963564 — PERSONAL LIMB HOLDER (24444-200,300,24444-KIT)
- K963750 — RETRIEVAL SNARE
- K963778 — CDR-CAM
- K964278 — WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6
- K964565 — PARAMAX AMMONIA AND AMMONIA BLANK REAGENT
- K951226 — VITALMAX 4000/MINIPACK 3100/3000
- K954923 — BACTEC FUNGAL MEDIUM
- K960512 — GEMINI PC-ITX
- K961407 — SPEED-CUT
- K962128 — TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT)
- K962389 — EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE
- K963323 — ENDO VIP
- K963344 — DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE
- K963462 — COMFOR FOAM LIMB HOLDERS- SINGLE STRAP
- K963554 — 24448-010 SECURE-ALL FINGER CONTROL MITT
- K963556 — SECURE-ALL 1-PIECE BODY HOLDER, SMALL/MEDIUM (24451-010,020,24452-010,020,030)
- K963557 — SYSTEM 2 ZIPPERED BODY HOLDER, SMALL/MEDIUM 24453-010,24453-020,24453-030
- K963561 — ULTRA CARE VEST STYLE BODY HOLDER, SMALL (24455-010,020,030,040,24456-010,020,030,040)
- K963563 — ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145)
- K963577 — RADIONICS SLUIJTER-MEHTA CANNULA
- K963611 — VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH
- K963773 — 24457-010 SECURE ALL PELVIC HOLDER/24458-010 SECURE ALL BODY BELT
- K964062 — N PROTEIN STRANDARD SL
- K960315 — FLAVORED LATEX PATIENT EXAMINATION
- K961606 — METRO FOCAL ASPHERIC (POLYMACON)
- K961917 — MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX)
- K963010 — LIFESTYLE GP (TELEFOCON B) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENS FOR DAILY WEAR
- K963327 — TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610
- K963488 — SPECIALTY PROGRESSIVE(METHAFILCON A)MULTIFOCAL SOFT(HYDROPHILIC)CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED)
- K963742 — LATEX EXAMINATION GLOVES, POWDERED
- K963809 — COOL-ZONE
- K963840 — CEDIA PHENYTOIN II ASSAY
- K964063 — RDI LDL PRECIPITATION REAGENT
- K964064 — RDI LIPIDIRECT MAGNETIC LDL REAGENT
- K964466 — PALLADIA 75 (PM-11)
Data sourced from openFDA. This site is unofficial and independent of the FDA.