FDA 510(k) clearances — page 928
clearances on record, most recent first.
Clearances — page 928
92,701–92,800 of 176,637- K973461 — ELITE POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE
- K973470 — COHERENT POPEYE OPHTHALMIC LASER SYSTEM, COHERENT POPEYE OPHTHALMIC LASER SYSTEM IN COMBINATION WITH THE COHERENT ARGONS
- K973576 — EPULSE MODEL 2940 ER:ASER ER:YAG LASER SYSTEM
- K974158 — ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY
- K963518 — COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR
- K973089 — FREEDOM
- K973091 — WAVE
- K973092 — STAE
- K973406 — OSTEONICS SERIES 7000 TOTAL KNEE AUGMENTED FEMORAL COMPONENT
- K973412 — NATURAL-KNEE II CONSTRAINED KNEE SYSTEM
- K973439 — ENDO ANALYZER, MODEL 8005
- K973468 — MODEL IRC 1199 SCOUT NEBULIZER
- K973472 — 3M CDI H/S CUVETTES WITH HEPARON TREATMENT
- K973485 — CLEARVIEW BLOWER/MISTER
- K973510 — DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML)
- K973528 — SUNGLASSES
- K973566 — SOWELL PATENTED NON-PRECIOUS METAL ALLOY
- K973749 — FRAG COMMANDER
- K973847 — AL-47 TORIC (ISOFILCON) SOFT (TORIC) DAILY WEAR CONTACT LENS
- K973967 — AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK)
- K973995 — RANDOX BILIRUBIN
- K974053 — AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10
- K974325 — CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN
- K974383 — ELECSYS CALCHECK VITAMIN B12
- K974384 — ELECSYS CALCHECK FOLATE
- K974414 — MULTI
- K963982 — ACIST ANGIOGRAPHIC INJECTOR
- K972228 — MERIDIAN TITANIUM FEMORAL STEMS
- K972790 — THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCR
- K972925 — ACCESS RADIOLOGY (FRAMEWAVE) TELERADIOLOGY IMAGE ACQUISITION AND DISTRIBUTION SYSTEM WITH PICTURE AND ARCHIVING COMMUNIC
- K973355 — ADVANTAGE 3000
- K973384 — ETHICON NON-STICK BIPOLAR FORCEPS
- K973385 — OVAL SHAPES
- K973421 — IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE(2100{SIKARUS X86}/(1500{WINDOWS NT}
- K973423 — STERI-OSS 3.25 MM REPLACE(HYDROXYAPATITE-COATED)DENTAL IMPLANT
- K973433 — STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANT
- K973616 — TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
- K973630 — CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM
- K973826 — SPHINCTEROTOME
- K973842 — CARBON FIBER CONFORMAL COUCH TOP
- K973882 — EL-B2GP1SCR
- K974003 — ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30
- K974047 — ACCUWELL PHENYLALANINE ASSAY
- K961289 — VAPOPHENE
- K970773 — POWDER-FREE EXAM GLOVES
- K971362 — PERSONAL INFUSOR
- K971650 — RHYTHMSTAT XL
- K971681 — SMC FEMORAL HIP COMPONENT
- K971824 — REACH FEMORAL HIP COMPONENT
- K971920 — GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)
- K972016 — AUTIMO 2.5-D AND AUTIMO 3-D
- K972649 — CARDIOCALL CARDIAC EVENT RECORDER
- K972767 — CANDELA GENTLELASE GL DERMATOLOGICAL VASCULAR LESION LASER
- K973146 — MENTOR SUPER ABSORBENT DRAPE
- K973206 — STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY
- K973354 — SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)
- K973411 — DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME)
- K973491 — MECHANICAL FOLDING WHEEL CHAIR
- K973509 — KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING
- K973703 — JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN
- K973771 — DENTAL/SURGICAL DRILLS, BURS, TAPS
- K973782 — AQUASIL XLV SMART WETTING IMPRESSION MATERIAL
- K973899 — UNIFINE PENTIPS
- K973976 — EPIC-FLO
- K973324 — STARLIGHT PULSED DIODE ARRAY LASER SYSTEM
- K973340 — TWEEZER-TYPE EPILATOR
- K973437 — HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULES
- K973742 — SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM
- K973784 — TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS
- K973798 — S-357 VIDEO IMAGING SYSTEM
- K952267 — CRITERION, CRITERION I.V., MODIFIED
- K965016 — ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)
- K971243 — OHMEDA INFANT RESUSCITATION SYSTEM
- K971440 — FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELECTROCARDIOGRAPH
- K971441 — QUANTA LITE TOXOPLASMA IGG
- K971735 — ACCUDEXA BONE DENSITOMETER
- K972230 — QUICKIE P90 SERIES
- K973302 — FOUNDATION POROUS HIP STEM
- K973304 — MVM 3.3 MM MICROENDOSCOPE
- K973315 — THERAPAX DXT 300 MODEL HF-300
- K973325 — BACT/ALERT FAN CULTURE BOTTLES
- K973332 — ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
- K973353 — BONDING BASE
- K973370 — AQUAPLAST PALATAL STENT
- K973415 — CURVILINEAR SUTURE PLACEMENT SYSTEM
- K973463 — OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE
- K973484 — CHIN DISTRACTOR
- K973611 — SPECTRASCIENCE REUSABLE BIOPSY FORCEPS
- K964622 — MEDI-DX 7000
- K964703 — THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
- K971205 — TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES
- K971335 — QUANTA LITE CMV IGG ELISA
- K972064 — MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUV
- K972112 — INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450
- K972457 — MONOCOL/LEX-IM TEST
- K973313 — INNOVASIVE DEVICES Y-KNOT SUTURE CLIP
- K973323 — ACL CLIP-IN
- K973429 — BIODERM FOAM WOUND DRESSING
- K973479 — CEFMETAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K973495 — GLENROE GLOW IN DARK ELASTOMERIC LIGATURES
Data sourced from openFDA. This site is unofficial and independent of the FDA.