FDA 510(k) clearances — page 1115
clearances on record, most recent first.
Clearances — page 1115
111,401–111,500 of 175,890- K931093 — QUICK-CONNECT 360 SWIVEL TIP AUTOCLAVABLE SYRINGE
- K931288 — ISOLAIR 2 FULL FACE SPLASH GUARD
- K931488 — KSF SPINAL FIXATOR
- K931621 — ACUFEX PRO-PAC AND ISO-PAC
- K931846 — BIO-PREP
- K932001 — ALLISON MEDICAL SYRINGE
- K933663 — MODIFICATION OF ACUSON V510B TRANSDUCER
- K934265 — FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE
- K934342 — GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM
- K934343 — GLASER RT60, RT80, RT150 AUDIOMETER
- K934347 — ANTIFOG
- K934405 — PRECEDENT
- K934845 — SONICATOR 715
- K934901 — TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVE
- K935250 — ACCU-PATH
- K935326 — NU-EAR SD-10 IN THE CANAL HEARING AID
- K935327 — NU.EAR SD-2 IN-THE-CANAL (ITC) HEARING AID
- K935328 — NU.EAR SS-2 IN THE CANAL (ITC) HEARING AID
- K935329 — NU.EAR AE-2 IN THE CANAL (ITC) HEARING AID
- K935330 — NU.EAR SS-3 IN THE CANAL (ITC) HEARING AID
- K935331 — NU.EAR SD-3 IN THE CANAL (ITC) HEARING AID
- K935332 — NU.EAR AE-1 IN THE EAR (ITE) HEARING AID
- K935333 — NU.EAR SS-1 IN THE EAR (ITE) HEARING AID
- K935334 — NU.EAR SD-1 IN THE EAR (ITE) HEARING AID
- K935335 — NU.EAR SS-10 IN THE CANAL (ITC) HEARING AID
- K935340 — COMFORT PLUS NIPPLE SHIELDS
- K935341 — COMFORT PLUS BREAST SHELLS
- K935567 — SODEM POWER SYSTEM
- K935601 — 0.22 MICRON FINAL FILTER WITH EXTENSION TUBE
- K935689 — IONOSIT BASE LINER
- K935714 — CRYSTALLINE L3 MULTI-USE HYBRID COMPOSITE
- K935727 — P&FS PIT AND FISSURE SEALANT
- K923299 — APLICARE ONE COMPUND BENZION TINCTURE SWABSTICK
- K926190 — ALRAND INC. (DENTAL HAND INSTRUMENTS)
- K931298 — SIGNA ADVANTAGE 1.OT MAGNETIC RESONANCE SYSTEM
- K933507 — NEEDLETUBE SYRINGE CARTRTIDGE
- K933603 — LEADWIRE
- K933758 — REGENCY PLUS BRACKET
- K934019 — EXCEL FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO
- K934378 — SCIMED MAVERICK PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
- K934696 — ANGIOSCOPE
- K935018 — REAGENTS FOR ORION 1020, AND RELATED ANALYZERS
- K935022 — SCIMED ENTRE II PTCA GUIDE WIRE MODIFICATION
- K935032 — ZENITH TOTAL ETCH 10% PHOSPHORIC ACID
- K935203 — WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL
- K935547 — CAL 1 AND CAL 2 STANDARDS/STANDARDS FOR IL 501 SODIUM/POTASSIUM ANALYZER
- K935817 — MEDSIM 300 PATIENT SIMULATOR
- K920634 — SPLITTABLE SHEATH INTRODUCER SET
- K925297 — RI-MED
- K925978 — MPC-80 TRANSDUCER
- K930854 — SOLUTION SET WITH .2 MICRON FILTER
- K931120 — COAXIAL ACUTE CATHETER
- K934465 — DIC TRACHEOSTOMY TUBE AND PORTEX BLUE LINE
- K934887 — 9750 ATHENA ETHERNET OPTION
- K934988 — 9 FRENCH LARGE LUMEN TRIGUIDE PLUS GUIDING CATHETER
- K935400 — FONIX 3500 HEARING AID ANALYZER
- K935553 — MULLY SUCTION STRAIGHT WITH FINGERTIP/WITH FUNNEL/WITH VACUTIP
- K935582 — TUBE, INHALER OXYGEN
- K935821 — DOUBLE TRACH SWIVEL CONNECTOR
- K935931 — NON-WOVEN SPONGE
- K935932 — BURN COMPRESS
- K935933 — CUSTOM BURN DRESSING
- K935935 — BURN GAUZE PADS
- K935936 — CONFORMING ROLL
- K935937 — POST OP SPONGE
- K935938 — BANDAGE ROLLS, STRETCH GAUZE ROLLS, TEXTURED GAUZE ROLLS
- K935939 — GAUZE FLUFF
- K935940 — GAUZE SPONGE; DRAIN SPONGE
- K935941 — READY CUT GAUZE GAUZE BOLTS
- K923664 — SCOLE 300 ECG RECORDER
- K925385 — REAGENTS FOR ABBOTT SPECTRUM/EPX (ELECTRO CALIBRA)
- K925464 — CALIBRATION SOLUTIONS FOR USE ON ELECTROLYTE INSTR
- K930199 — ALKO FLUIDS PACKS FOR NOVA ANALYZERS
- K930231 — ALKO CALIBRATION FOR AMDEV LYTENING SYSTEMS
- K930796 — ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS
- K931521 — POWDER FREE LATEX EXAMINATION GLOVES
- K932368 — UROPAPER EIKEN 6B
- K932812 — EC 5R PLETHYSMOGRAPH
- K934279 — PHX TECHNOLOGIES CORP., 5MM, 10MM, AND 12MM BLUNT-TIPPED TROCAR OBTURATORS AND MATCHED TROCAR TUBES
- K934280 — PHX TECHNOLOGIES CORP., 10 MM THORACOSCOPY SCRAPPER DEVICE
- K934891 — AMPHETAMINES EIA ASSAY MODIFICATION
- K935180 — ALANINE AMINOTRANSFERASE (ALT) TEST
- K935258 — HYBRID SURGICAL DEVICE MODIFICATION
- K935366 — BINAURAL HEARING AID
- K935591 — CEDIA DAU MULTI-LEVEL THC ASSAY
- K935942 — SURGICAL LAPAROTOMY SPONGE X-RAY DETECTABLE
- K925004 — ALLKARE BARRIER WIPE
- K925011 — NEBULIZER PUMP, POWERED MODEL 1180
- K933495 — MPM GELPAD (HYDROGEL SATURATED STERILE GAUZE PADS)
- K933978 — NEDBOND EJECTOR KERRISON RONGEUR
- K935797 — SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE
- K935835 — BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIES
- K922997 — VIA 1-01 INFUSION PUMP/BLOOD CHEM. SYST. -- MOD.
- K930810 — TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY
- K931136 — APOLLO CAMERA
- K931501 — NUMED DISPOSABLE ATT. NUMED HANDLE LAP. INST.
- K932020 — ENTREE BLUNT TIP TROCAR AND ADAPTER
- K932021 — ENTREE CANNULA FASCIA ANCHORS
- K932072 — JARIT SURGICAL INSTRUMENTS
- K933078 — BECKMAN ALPHA-1-MICROGLOBULIN (A1M) REAGENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.