FDA 510(k) clearances — page 991
clearances on record, most recent first.
Clearances — page 991
99,001–99,100 of 175,890- K955513 — SURGICAL MASK (NON-STERILE)
- K960323 — KARL STORZ GELET URETERO-RENOSCOPES/KARL STORZ ALKEN MOTION CONTROL DEVICE
- K960348 — OSTEOGRAF/N-300 HYDROXYLAPATITE
- K960510 — THERAVIEW
- K960993 — PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)
- K953901 — SARNS 800 ROLLER PUMP
- K953904 — SARNS 9000 UNIVERSAL ROLLER PUMP
- K955450 — PATHROMTIN SL
- K955602 — RELSIA SCL-70 ANTIBODY TEST SYSTEM
- K955603 — RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM
- K955604 — RELISA SM/RNP ANTIBODY TEST SYSTEM
- K955605 — RELISA JO-1 ANTIBODY TEST SYSTEM
- K960139 — G.E. STERILE ANGIOGRAPHIC TRAY
- K960240 — RUSCH OPTOSAFE
- K960294 — PHASE CONJUGATE SYMMETRY OPTION FOR OUTLOOK
- K960312 — RDI CARDIAC INSULATION PAD
- K960450 — HEBELER SAFE-T-TUBE
- K960702 — CRP-LATEX SEIKEN XR REAGENT SYSTEM
- K960703 — RF-LATEX SEIKEN REAGENT SYSTEM
- K960949 — PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167
- K961071 — THE MAGNUM CHIN IMPLANT
- K961072 — PEC IMPLANT
- K961080 — MEDIAL MALAR IMPLANT
- K961124 — THE NAUTILUS
- K931336 — DRS 4 DIALYZER REPROCESSING SYSTEM
- K933469 — UNIVEC NON-REUSABLE SYRINGE
- K943104 — MOLLOY INTUBATING STYLETTE
- K950688 — OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM
- K952712 — WHITE RIVER BATTERY-POWERED BREAST PUMP
- K954549 — SURGICAL APPAREL
- K954814 — ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY
- K954815 — ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY
- K954829 — ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY
- K954832 — ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY
- K955717 — ENDOSCOPE INTRODUCER KIT
- K955859 — IMMUNOCARD TOXIN A
- K960311 — PERINEOMETER
- K960353 — OSTEOGRAF/LD-300 HYDROXYLAPATITE
- K960368 — OSTEOGRAFT/N-700 HYDROXYLAPTITE
- K960439 — LM BONE ANCHOR
- K960451 — WEBB-MORLEY SPINE SYSTEM
- K960516 — FASTAK SUTURE ANCHOR
- K960626 — MODULAR ONCOLOGY SYSTEM TECHNOLOGY (MOST)
- K960938 — PROV-KB
- K960996 — M. CAT BUTYRATE DISK
- K961084 — AM 400
- K961285 — ARGEDENT 40(GOLD-PALLADIUM-SILVER ALLOY FOR PORCELAIN APPLICATION)
- K932661 — WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180
- K944459 — ACCU-CHEK INSTANT PLUS G-C/DM BLOOD GLUCOSE MONITORING SYSTEM
- K952435 — CELSITE PEDIATRIC VENOUS SYSTEM
- K952797 — AT53 DUAL CHANNEL EMG
- K953522 — USCI IDEAL PTCA KIT
- K953716 — INTRACAVITY TRANSDUCERS
- K954955 — STORC INTRAUTERINE PRESSURE CATHETER
- K960071 — IMAGEFUSION
- K960285 — MEDI-JECT CORPORATION MEDI-JECTOR NEEDLE-FREE BIO-TROPIN DDRUG DELIVERY SYSTEMS 0.0058/0.0068(INCH DIAMETER NOZZLEORIFIC
- K960341 — TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS
- K960382 — KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER
- K960448 — LM ANCHOR
- K960921 — CODAN MEDLON BC110 VIAL ADAPTER CODAN SPIKE
- K961119 — CAREFREE PANTYLINERS
- K961129 — AREMA II
- K932994 — EVOKED POTENTIAL SYSTEM-1.0
- K945957 — AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER
- K950972 — REAL-TIME RECONSTRUCTION SYSTEM MODEL TSXF-001A
- K951359 — RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC DEVICE
- K951994 — OLYMPUS EU-M30 ENDOSCOPIC ULTRASOUND CENTER
- K953185 — PLATINUM SERIES EP DIAGNOSTIC CATHETERS
- K954272 — INNOVA RECTAL STIMULATON ELECTRODE
- K954471 — POWERS ANTI-BACTERIAL VALVE
- K954735 — ENTERALITE
- K954842 — D.O.R.C. VFI/VFE SYSTEM
- K954967 — GUTHRIE POWDERFREE LATEX EXAMINATION GLOVES
- K955108 — CARDS Q.S. STREP A
- K955176 — DENTO-SURGE
- K955419 — POWDER FREE TACTYLON SURGEONS GLOVE
- K960144 — G.E. STERILE CT BIOPSY TRAY
- K960169 — CARBOMEDICS VALVE TESTER
- K960195 — THYROCHEK ONE-STEP RAPID TSH ASSAY
- K960216 — CPR SUCTION CATHETER KIT
- K960262 — CORING MORCELLATOR
- K960292 — GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS
- K960350 — THERAPORT VASCULAR ACCESS SYSTEM; MODEL 1001, 1002, 1601, 1602
- K960351 — Q-LUX LIGHT CURE UNIT
- K960361 — PERMAMESH-D HYDROXYLAPATITE MATRIX
- K960364 — CU-200 LIGHT CURE UNIT
- K960514 — TMP MANDIBULAR COMPRESSION SYSTEM (MODIFICATION)
- K960542 — NOGA
- K960698 — NON-CORING NEEDLE
- K960732 — HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500
- K960906 — FOUNDATION GLENOID COMPONENT
- K961025 — EXPANDED BODY SUTURE
- K961177 — CAROLINA NARROW FABRIC COMPANY CLOSED TOE ANTI-EMBOLISM STOCKING
- K943338 — BIOSENSOR BIDOP VASCULAR TEST SYSTEM
- K953872 — SECOND EAR BONE CONDUCTION HEARING AID
- K954353 — MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
- K954354 — MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
- K954567 — RTI MEDICAL
- K954759 — FLOWMATE LTE
- K955251 — OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM
Data sourced from openFDA. This site is unofficial and independent of the FDA.