FDA 510(k) clearances — page 500
clearances on record, most recent first.
Clearances — page 500
49,901–50,000 of 176,542- K100951 — MEDTOX BUPRENORPHINE TEST
- K101193 — PMC LAPAROSCOPIC INSTRUMENTS
- K101597 — WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4
- K101626 — LENSX LASER SYSTEM
- K101911 — IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY
- K101933 — MODIFICATION TO:EXPEDIUM SPINE SYSTEM
- K102239 — CARESCAPE MONITOR B650
- K102485 — RE-TRACE URETERAL ACCESS SHEATH
- K102721 — LIVEWIRE ELECTOPHYSIOLOGY CATHETER
- K100687 — VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120
- K102163 — REALSEAL XT SEALER
- K092274 — RANDOX BENZODIAZEPINE ASSAY
- K093545 — PINPOINTE FOOTLASER MODEL 6W, 30W, 100W
- K093547 — PINPOINTE FOOTLASER
- K093833 — KAPSS SPINAL SYSTEM
- K101351 — NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT
- K101811 — PROTEGRITY SMT LATEX SURGICALGLOVES
- K101955 — ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058
- K102024 — RPM RESPIRATORY GATING SYSTEM
- K102331 — LDR SPINE USA SPINETUNE TL SPINAL SYSTEM
- K102435 — BEYONDIMAGE WORKSTATION
- K102672 — TARGET DETACHABLE COIL
- K102686 — MYOSURE ROD LENS SCOPE SEALS
- K102774 — VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER
- K102920 — ELECTRONIC BLOOD PRESSURE MONITOR
- K092593 — PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)
- K093562 — ENDOSSEOUS DENTAL IMPLANT
- K101848 — SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM
- K101864 — KYPHON XPANDER II INFLATABLE BONE TAMP
- K093093 — SMALL PLATEAU SPACER SYSTEM
- K094060 — QUANTA FLASH H-TTG IGA
- K100310 — BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS
- K100593 — SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME
- K101149 — GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
- K101271 — HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX
- K101518 — COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE
- K101859 — REL-K ARTIFICAL LIMB PROSTHESIS
- K102041 — AIXPLORER
- K102325 — IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD)
- K100071 — EMCOOLSPAD
- K100580 — EXSALT WOUND DRESSING
- K101700 — IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM
- K101987 — COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593
- K102000 — IMAGYS
- K102671 — SYNGO RT THERAPIST CONNECT WORKSPACE, V4.2
- K092407 — REMEL SPECTRA MRSA
- K100011 — FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM
- K100653 — JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD
- K101096 — HT III SA FIXTURE SYSTEM
- K101177 — APEXNRG RIDER
- K101331 — LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE
- K101594 — POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
- K101670 — UNITED U2 BIPOLAR IMPLANT
- K101787 — DUOLINK II
- K102059 — AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017
- K102071 — OSTENE CT, AOC CT, OSTEOTENE, CERETENE
- K102161 — BLUE SAIL INNOVATION
- K102450 — IONOLUX PRO
- K102608 — SECURMARK BIOPSY SITE MARKING SYSTEM
- K092599 — IMMULISA MPO ANTIBODY ELISA
- K092600 — IMMULISA PR3 ANTIBODY ELISA
- K092601 — IMMULISA ANCA SCREEN ELISA
- K092973 — DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE
- K100077 — NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-FINGER SENSOR, MODEL T100A-090103
- K101166 — 4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ
- K101280 — MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE
- K101939 — OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM
- K102133 — GIRAFFE2
- K102248 — EXCELLA II SPINAL SYSTEM MODEL EC2-00
- K102269 — ELECSYS IGE CALCHECK 5
- K102476 — TELERADPRO
- K102529 — D2RF DIGITAL DYNAMIC REMOTE SYSTEM
- K102556 — VOLPARA, VERSION 1.3
- K102582 — ARTERIOFLOW MODEL 7500 SEQUENTIAL COMPRESSION DEVICE
- K102604 — I-LOGIC INREACH SYSTEM
- K102632 — ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER
- K102728 — ARSTASIS ACCESS SYSTEM
- K092398 — HSV STRAW
- K093438 — PARADIGM INTERSPINOUS FUSION PLATE
- K093683 — ORTHOPANTOMOGRAPH OP300
- K100123 — ACUMED WRIST ARTHRODESIS PLATE SYSTEM
- K100933 — CONSENSUS CS2 PLUS ACETABULAR INSERT
- K101760 — ELEGANT BLUE, WHITE, PINK POWDER FREE, NITRILE EXAMINATION GLOVES
- K102006 — CRYOMEGA
- K102089 — GRAND WORK PLASTIC PRODUCTS CO., LTD. POWDER FREE VINYL PATIENT EXAMINATION GLOVES
- K102092 — PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES
- K102099 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES
- K102277 — INTERFUSE T INVERTEBRAL BODY FUSION DEVICE
- K093816 — DIGITAL RADIOGRAPHY SYSTEM, MODELS GALAXY 900 AND 1600
- K093893 — SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
- K100356 — TDS PRECISION DENTAL BAR
- K100903 — ANTI-HAV
- K100991 — IMC SURGICAL DRAPE
- K101324 — GE ECHOPAC MODEL BT10
- K101365 — ELECSYS CA 19-9 CALCHECK 5
- K101586 — XTRA AUTOTRANSFUSION SYSTEM
- K101657 — RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 40
- K101768 — MIE SCINTRON GAMMA CAMERA SYSTEMS
- K101809 — FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20
- K101813 — IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO
Data sourced from openFDA. This site is unofficial and independent of the FDA.