FDA 510(k) clearances — page 1225
clearances on record, most recent first.
Clearances — page 1225
122,401–122,500 of 176,637- K911244 — VLC GLASS IONOMER LINER
- K911276 — MAGNETIC RESONANCE DEVICE ACCESSORY
- K911338 — LIMA CEMENT RESTRICTOR
- K911410 — PS MEDICAL BUTTON VALVE
- K911412 — OLYMPUS DISPOSABLE BIOPSY VALVE
- K911420 — HISTOFREEZER
- K911445 — FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM
- K911528 — ISOLA(TM) SPINE SYSTEM - ILIAC SCREW
- K911548 — ACRYL-X SYSTEM TM
- K911552 — ANATOMIC TOE SYSTEM
- K911613 — VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4
- K911703 — CORDIS 8 FRENCH 0.084 I.D. PTCA GUIDING CATHETER
- K911773 — PHILIPS TELESCAN
- K911806 — MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
- K911902 — TEMPERLITE(TM) SAW BLADE
- K912128 — MAXI-SCOPE OR ULTRA-SCOPE
- K912466 — OLDELFT SIMULIX-MC
- K905569 — ELECTRO-NERVE STIMULATOR TENS,MODEL SYSTEMS PLUS/A
- K910807 — KEANE UNI KNEE SYSTEM
- K910890 — NON-STERILE CLINICAL STYLE PARADERM GLOVE LINER
- K911161 — INERPAN(TM) TEMPORARY WOUND DRESSING
- K911398 — ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM
- K911628 — SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%)
- K911629 — SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%)
- K911668 — CERAPALL 2
- K911675 — PAGALIN 2
- K911677 — SELECTOR 3
- K911684 — BIOMET COBALT-CHROME FEMORAL COMPONENTS
- K912083 — LATEX PATIENT EXAMINATION GLOVES, HYPOALLERGENIC
- K912252 — INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT
- K911368 — MAICO MA800 AUDIOMETER
- K911373 — OSTEONICS ION IMPLANT MOD-ML UNIKNEE FEMORAL COMP
- K911810 — SIEMENS MODEL 604 PP, BEHIND-THE-EAR HEARING AID
- K911811 — SIEMENS MODEL 604 PP-L, BEHIND-THE-EAR HEARING AID
- K912297 — VS1G
- K912298 — VS1
- K912299 — VS1B
- K912300 — VS11
- K912303 — STANDARD S1
- K912304 — STANDARD S2
- K912306 — STANDARD S4
- K912309 — STANDARD S33
- K912570 — PHONAK PHONICA MODEL 312-C ITE HEARING INSTRUMENT
- K912571 — PHONAK PHONICA MODEL 312-SC ITE HEARING INSTRUMENT
- K903001 — SLIMCATH (TM)
- K905092 — NEUROMUSCULAR TRANSMISSION MONITOR
- K910116 — TURBO SUPPORT CATHETER
- K910769 — SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM
- K911099 — MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE
- K911298 — PRESSURE LIMITING ELBOW WITH MANOMETER PORT
- K911384 — CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600
- K911460 — .010 HI-TORQUE GUIDE WIRES WITH PRESHAPED TIP
- K911721 — KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION
- K911808 — GEMINI OPHTHALMIC SURGERY SYSTEM
- K912026 — DELFIA(R) 17 -OH-PROGESTERON KIT
- K912366 — MAINSTER HIGH MAGNIFICATION LASER LENS
- K895363 — BIOVISION EMERALD LASER PHOTOCOAGULATOR
- K901552 — (CP) TITANIUM AND TI6AI-4V ALLOY FOR FIXED PROSTHE
- K903418 — LATERALASE TM
- K904416 — CROATEST (R) RHEUMATOID DIAGNOSTIC
- K904583 — SONO-VU US(TM)
- K904600 — L582 TRANSDUCER
- K904890 — BARD ALFENTANIL INFUSER
- K905024 — TMP MANDIBULAR COMPRESSION SYSTEM
- K905613 — MTS KNEE SYSTEM
- K910177 — SEAL-RITE SILICONE EAR PLUG
- K910462 — POCKET DOP 3
- K910487 — VISUWELL SYPHILIS ANTIGEN
- K910602 — HGM ARGON ION & SOLID LIGHT LASER FOR DENTISTRY
- K910833 — COLOR VUE TM- MYCOPLASMA PNEUMONIAE
- K910910 — MOSS- ANCHOR SET
- K910916 — CATHLAB SILICONE OCCLUSION BALLOON CATHETER
- K910934 — FLO-GARD 6300 DUAL CHANNEL VOLUMETRIC INFUSION PUM
- K911045 — OBA(TM) READER
- K911047 — OBA(TM) SERUM HCG ASSAY
- K911324 — IRRIGATION/ASPIRATION TUBING SET
- K911341 — HARMONIC SCALPEL ENDOSCOPIC BLADE COUPLER EXTENSIO
- K911353 — EMC MODEL NO. STATOME 900
- K911421 — CATHETER MOUNTS
- K911425 — ACCESSORIES & CONNECTORS, 22MM-15MM-8.5MM
- K911429 — VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED
- K911449 — VITAL-PORT VASCULAR ACCESS SYSTEM
- K911496 — FASTTECH SYSTEM 1
- K911506 — MODEL 2100 PORTABLE FIELD UNIT
- K911634 — MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST
- K911753 — INTERVASCULAR ADMINSTRATION SET
- K911760 — MONARCH STERILIZATION CONTAINER SYST, MODIFICATION
- K911780 — INFANT NASAL CANNULAE ASSEMBLY, MODIFIED
- K911868 — INTERLINK(TM) BLUNT CANNULA, MODIFICATION
- K912044 — MODEL 700 LAPAROSCOPIC ELECTRONIC INSUFFLATOR
- K912149 — HARDCOATED PLASTIC FILLING INSTRUMENT
- K912348 — SX90 (TM),MODEL 4800S
- K912458 — MODEL 404-SP AND 504-SP INFUSION PUMPS MODIFIED
- K912544 — BIPOLAR FORCEPS
- K903013 — LYME IGM ELISA TEST
- K904239 — SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES
- K904298 — EURO-DIAGNOSTIC BLOOD PRESSURE MONITOR
- K904519 — AGFA DIAGNOSTIC CENTER (ADC)
- K904676 — NDI MODEL IRS-TD
- K905074 — MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM
Data sourced from openFDA. This site is unofficial and independent of the FDA.