FDA 510(k) clearances — page 907
clearances on record, most recent first.
Clearances — page 907
90,601–90,700 of 175,890- K980327 — MICROSTREAM FILTERLINE ICU
- K980356 — CERVICAL CYTOLOGY C-BRUSH MODEL CMB-1010
- K980358 — SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEM
- K980363 — ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI)
- K980395 — GLADRAGS COTTON MENSTRUAL PAD
- K980473 — PRESS-FIT STEM
- K980736 — ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST
- K980982 — AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 2
- K981038 — COAMATIC FACTOR VIII
- K981097 — STRATUS CS CKMB CALPAK
- K981100 — STRATUS CS TROP CALPAK
- K981106 — UREA NITROGEN (BUN) LIQUID REAGENT
- K981165 — AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST
- K971157 — MACRALP(A) ENZYME IMMUNOASSAY KIT
- K971402 — BARD BTA TRAK TEST
- K973562 — IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9100
- K980134 — KSEA N2O ENDOFLATOR
- K980525 — UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD
- K980537 — ND: YAG ACCESSORY FOR PHOTODERM SYSTEM
- K980599 — NTECH ARTHROSCOPE
- K980720 — NONWOVEN PAD
- K980924 — PLANCON MICROLAMELLAR KERATOME EVOLUTION
- K980991 — NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER
- K981051 — SOFT TISSUE PATCH PLUS, DUALMESH PLUS, MYCROMESH PLUS, DUALMESH PLUS WITH HOLES
- K981101 — STRATUS CS MYO CALPAK
- K971400 — MUSCLE RESPONSE MONITOR
- K972201 — PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE
- K972546 — RUSCH SINGLE USE CRYSTAL TRACHEOSTOMY TUBE SET
- K972783 — BIOFIX BIODEGRADABLE THREADED SUTURE ANCHOR
- K973613 — CH-611B AND CH-611C DIGITAL WRIST SPHYGMOMANOMETERS BLOOD PRESSURE METER
- K974510 — ENVOY PATIENT MONITOR
- K980228 — UNIVERSITY PLATE ANTERIOR SYSTEM
- K980368 — DEPUY MOTECH PEAK 3MM FIXATION ROD SYSTEM
- K980370 — BIOSYMMETRIC PROXIMAL INTERPHALANGEAL JOINT FIXATOR
- K980447 — DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
- K980486 — IMPLEX HEP ACETABULAR REVISION CUP, CEMENTED OR CEMENTLESS MODEL A-240 SYSTEM
- K980496 — WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER
- K980513 — ARTICUL/EZE FEMORAL HEADS
- K980543 — DENOPTIX BARRIER ENVELOPE (SIZE 0-4)
- K980589 — AR SAFE NITRILE EXAMINATION GLOVES
- K980605 — LOW PROTEIN LATEX PATIENT EXAMINATION GLOVES (POWDER-FREE)
- K980147 — YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION
- K980157 — PREMIER 7000 CTL SPINE COIL
- K980169 — HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS
- K980176 — HISPEED QX/I CT SCANNER SYSTEM
- K980179 — SHARPS PLUS 5 GALLON SHARPS CONTAINER
- K980474 — TELICAM
- K980695 — FUJI I
- K970961 — VAPORIZATION ELECTRODES
- K971726 — CV PERI-GUARD - CARDIOVASCULAR PATCH
- K972647 — CO2 PNEUMO-DISSECTOR
- K980104 — FLOW RIDER FLOW DIRECTED MICRO CATHETER
- K980110 — ENDOCRE CRYOCARE CRYOSURGICAL SYSTEM
- K980145 — AMT DECOMPRESSION TUBES
- K980503 — TEMPORARY CARDIAC PACING WIRE
- K965034 — SORBASTACE
- K970761 — LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND)
- K970768 — HUMAN LYME IGM WESTERN BLOT KIT
- K974059 — ONE STEP MIDSTREAM HCG PREGNANCY TEST
- K974060 — MINISTRIP/ SERUM AND URINE COMBO HCG TEST
- K974097 — PERIACRYL
- K980079 — COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES
- K980081 — S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD
- K980091 — LUBRISCAN ULTRA SCAN GEL +, MODEL RG2-60
- K980099 — ULTRACISION LAPAROSONIC COAGULATING SHEARS (LCS-5(LCSK5 AND LCSB5))
- K980159 — OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01
- K980235 — REMOTE HAND CONTROL TO THE INFLATABLE POSITIONING CUSHION (A.K.A. IMAGEAIR)
- K980451 — BIODERM CALCIUM ALGINATE DRESSING
- K980471 — KHT GUAM NEEDLE, ACUPUNCTURE NEEDLE
- K980472 — KHT SOFT NEEDLE, ACUPUNCTURE NEEDLE
- K980541 — BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY
- K980617 — MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER
- K980768 — VACUETTE HOLDEX
- K963703 — ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000)
- K964205 — BETTER-TUBING
- K973697 — AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY
- K974302 — LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B
- K980237 — GYNEX ENDOSPECULUM
- K980314 — FETAL D TECTION KIT
- K980412 — COLOURED POWDWR-FREE SURGICAL GLOVES
- K980889 — URESIL NEPHRO-URETERAL STENT
- K973064 — KEELER TEARSCOPE-PLUS
- K980505 — HORTMANN AMDIS-OAE OAE ANALYZER
- K980554 — ALDEN CLASSIC TINTED (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS, TINTED (TRANSPARENT/ENHANCING)
- K980627 — NEVA SYSTEM
- K974742 — MANAN POTTS-COURNAND NEEDLE
- K974743 — MANAN
- K974745 — MANAN GWI GUIDE WIRE INTRODUCER
- K980151 — RELEASABLE FORCE MODULE
- K980336 — IV STANDS
- K980470 — KHT SOFT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE
- K980871 — LYPHOCHEK WHOLE BLOOD CONTROL
- K972824 — THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER
- K973334 — OZ POWER SYRINGE
- K973704 — PROFUSION BONE VOID FILLER
- K974380 — REJUVENESS
- K980020 — ACTIVELOCK MODULAR FEMORAL HIP SYSTEM
- K980044 — XENON 300MX
- K980102 — BTI HUMERAL INTRAMEDULLARY ROD SYSTEM
- K980113 — WALLSTENT ENTERAL ENDOPROSTHESIS
Data sourced from openFDA. This site is unofficial and independent of the FDA.