FDA 510(k) clearances — page 888
clearances on record, most recent first.
Clearances — page 888
88,701–88,800 of 175,890- K983091 — ELAN-2
- K983184 — MEPILEX
- K983709 — SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1
- K980977 — PIOLAX HYDROPHILIC GUIDEWIRE
- K982948 — ELECSYS PSA, MODEL # ELECSYS 1010
- K982949 — ELECSYS PSA, MODEL 2010
- K983014 — SUMMIT ACETABULAR SYSTEM
- K983339 — OSTEO DYNATROC PROXIMAL FEMORAL NAIL
- K983510 — CHEMSTRIP 101 URINE ANALYZER
- K983548 — FERRITIN CALIBRATOR
- K981613 — COBE SMARXT TUBING AND CONNECTORS
- K982624 — MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242
- K982636 — PATIENT WARMER- MODEL PW810
- K982890 — ADVANCED UROSCIENCE INJECTION NEEDLE
- K982892 — 3M TEGASORB THIN HYDROCOLLOID DRESSING
- K982893 — 3M TEGASORB HYDROCOLLOID DRESSING
- K983197 — SURGICAL DYNAMICS RODDING SYSTEM (PREVIOUSLY KNOWN AS THE AURORA TITANIUM SPINAL ROD SYSTEM)
- K983265 — DEPUY ACE COMPOSITE LOCKING NUT
- K983639 — ZIPPIE GS, MODEL # EIZGS
- K981791 — MG
- K982128 — SHIKANI-FRENCH SPEAKING VALVE
- K982604 — LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEM
- K982689 — WINSTATION RETINAL IMAGER
- K982725 — OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE
- K983077 — BIO PONTOSTAR
- K983078 — BEGOPAL
- K983079 — PLATINLLOYD 100
- K974395 — ATLANT'S
- K980410 — SLE ELECTRODES AND ACCESSORIES
- K980590 — VARISOURCE HENSCHKE TYPE GYN APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER
- K980828 — EXMOOR MYRINGOTOMY KIT
- K981209 — MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS
- K981490 — WILLI GELLER CREATION PORCELAIN
- K982133 — OLYMPUS ENDOSCOPIC SYSTEM LUMBAR HERNIA DISCECTOMY AND ITS ANCILLARY EQUIPMENT
- K982255 — MODEL 2000 PULSE OXIMETER
- K982533 — UNICAP GLIADIN IGA ASSAY
- K982576 — FRIALIT-2 AUROBASE MODEL NUMBERS 45-2446, 45-2456, 45-2466, 45-2476
- K982580 — BIRD MONITOR INTERFACE
- K982593 — LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE
- K982692 — STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC
- K982701 — UNICAP GLIADIN IGG ASSAY
- K982714 — BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY
- K982761 — JOINT MOTION DEVICE PACKAGE PN 1032,KNEEL CERVICAL PN 1026, LUMBAR 1027, WRIST 1028, ANKLE 1029, SHOULDER 1030, HIP 1031
- K983018 — ZINC PHOSPHATE CEMENT
- K983057 — ORTHOPHOS 5/PLUS/CD
- K983107 — VFE
- K974891 — ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013
- K980485 — ISOLA SPINAL SYSTEM
- K980601 — VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADER
- K981004 — SLE EMG ELECTRODES AND ACCESSORIES
- K981208 — TFR
- K982013 — MGB LAPALUX TELESCOPE
- K982566 — AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM)
- K982577 — NEUFINISH RESURFACING CREAM
- K982592 — DOCKING-EXTENSION WIRE
- K982642 — ECHO-SCREEN
- K982778 — BIODERM FOAM WOUND DRESSING
- K982787 — ASTEION CT SCANNER, TSX-021A
- K982818 — HOSPAL TIPSTOP
- K982862 — RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE
- K982873 — ZETA MULTIZONE SCN LOCKING NAIL
- K982896 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9
- K982903 — SULZER ORTHOPEDICS FLUTED STEMS
- K982931 — THREADED FIXATION PIN
- K982936 — OSTEONICS EXTENDED FEMORAL BEARING HEAD
- K982953 — TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES
- K982984 — ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS
- K982987 — SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM
- K982990 — TSRH SPINAL SYSTEM
- K982991 — ANSPACH ACCESS CRANIAL PERFORATOR
- K982998 — GREINER MINICOLLECT SERUM GEL BLOOD COLLECTION TUBE
- K983053 — ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AND NON-SIGHTED EYES)
- K983058 — CERALAS D LASER SYSTEM, MODEL # CERALAS D15
- K983186 — BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR
- K983224 — XPS DRILL SYSTEM
- K983258 — MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTEM
- K983260 — MODIFICATION TO SPINAL CONCEPTS BACFIX TI SPINAL FIXATION SYSTEM
- K983316 — ULTRACISION 5MM INSTRUMENTS
- K983416 — ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353
- K981880 — DX-480, ADD ON DIGITAL IMAGER
- K982699 — UNIGRAFE
- K982888 — VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM
- K983037 — ROEKO SEAL
- K981958 — LEISEGANG VIDEO COLPOSCOPE
- K982299 — SPYGLASS 5 FR ANGIOGRAPHIC CATHETER
- K982545 — BMP CABLE SYSTEM
- K982548 — MLT 30 LASER
- K982671 — SECURALLOY
- K982695 — GC RELINE
- K982913 — ZINFOS ZINC PHOSPHATE CEMENT
- K982966 — DISETRONIC PEN
- K983052 — PERITRON PERINEOMETER MODEL 9300V OR 9300A
- K983381 — VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS
- K983406 — SANITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR MERCURY THERMOMETER, SENITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR
- K965136 — UROSURGE UROTHERM FLUID WARMING SYSTEM
- K974774 — ENVY GUIDING CATHETER
- K980078 — PENETREASE
- K980724 — TINAQUANT B 2-MICROGLOBULIN ASSAY
- K980907 — AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY
- K981660 — Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters
Data sourced from openFDA. This site is unofficial and independent of the FDA.