FDA 510(k) clearances — page 892
clearances on record, most recent first.
Clearances — page 892
89,101–89,200 of 176,637- K983419 — HOFFMANN II MIAMI POST
- K983440 — ABBOTT ARCHITECT TOTAL T4
- K983469 — PRECISET SERUM PROTEINS CALIBRATOR
- K983726 — GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
- K983788 — AARON COOLPAD SPLIT W/O CORD,AARON COOLPAD SPLIT WITH CORD, AARON COOLPAD W/O CORD, ARRON COOLPAD WITH CORD, MODELS ESRE
- K983859 — SPECTRUM SMALL FRY
- K983895 — IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT
- K983910 — ARTHRO-SURGIMAT-1500
- K983913 — MODIFICATION TO BIO-LOGIC SLEEPSCAN
- K983963 — DORNIER MEDILA H
- K983970 — IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5
- K984070 — ARCHITECT FREE T4 MASTERCHECK, LIST NO. 6C50-05
- K984073 — ARCHITECT TOTAL P-HCG MASTERCHECK, LIST NO. 6C21-05
- K981343 — ERCO-RIBBON
- K981357 — ERCO-VAC
- K981909 — BAXTER HEMOSTASIS VALVE INTRODUCERS
- K982416 — SHUN-THAI - SAFE-CONTACT, BOSTON MEDICAL LATEX EXAM GLOVE, SHUN-THAI LATEX EXMINATION GLOVE
- K982536 — PERFUSION CT (COMPUTED TOMOGRAPHY) SOFTWARE PACKAGE
- K982667 — MICROMEDICS NASAL SEPTAL BUTTON
- K982795 — PHILIPS BUCKY VISION
- K982956 — FLOWMATE II PLUS, MODEL #4000
- K982976 — ULTRASOUND WORKSTATION, UIWS-300A
- K982986 — TUBING BLOOD FLOW METER MODEL NUMBER HD-800
- K983325 — IN-PROBE II URODYNAMIC SYSTEM
- K983819 — INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN
- K983861 — DISTAFLO BYPASS GRAFT
- K984072 — ARCHITECT TSH MASTERCHECK, LIST NO, 6C52-05
- K981249 — METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTC 21-D
- K981379 — AURORA
- K981412 — M1145 (UPS1-1.25K-1G-MP) UPS
- K981768 — STEALTHSTATION TREATMENT GUIDANCE PLATFORM
- K982354 — SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BOLT 80/140, TOB 6 WASHER MODELS 12MM 16MM 1M
- K982965 — ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES
- K982971 — ORATEC TAC-C, MONOPOLAR CAUTERY PROBE
- K982978 — MODEL 340GE-21C QUADRATURE BRAIN COIL
- K983006 — OSTEO 5.0MM CANNULATED SCREW SYSTEM
- K983035 — CUSTOM FLANGED ACETABULAR COMPONENT
- K983480 — BPOS-IVAD STABILIZER
- K983549 — QUADRANT ANTERIOR SHINE
- K983763 — SPECTRUM SPIRIT
- K983818 — MITEK FASTIN RC ANCHOR
- K983916 — V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER)
- K980278 — URESIL VASCU-FLO INFUSION CATHETER
- K981277 — PERIFORM
- K981530 — SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM
- K981820 — NEUROMAP
- K981975 — LATEX PATIENT EXAMINATION GLOVE POWDERFREE (BLUE COLOR) POLYMER COATED
- K982188 — STERI-PAK BOWIE DICK TEST PACK
- K982759 — AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U
- K982958 — ZETA MULTIZONE LOCKING NAIL SYSTEM
- K982963 — POLYMER THREADED ANCHOR / SUTURE COMBINATION
- K983252 — SYSTEM U3 FOR GENTAMICIN
- K983253 — PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT
- K983307 — MODIFICATION TO PORTABLE INTENSIVE CARE UNIT
- K983417 — ABBOTT ARCHITECT FREE T4
- K983434 — ABBOTT ARCHITECT TOTAL T3
- K983439 — ABBOTT ARCHITECT FREE T3
- K983442 — ABBOTT ARCHITECT TSH
- K983754 — STANDARD CHIN
- K983755 — NASAL DORSAL SERIES
- K983756 — SURGIFORM ANATOMICAL MALAR
- K983838 — ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
- K983981 — BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE
- K984074 — ARCHITECT TOTAL T4 MASTERCHECK, LIST NO. 6C49-05
- K974738 — ASTRA TECH IMPLANT DENTAL SYSTEM
- K982010 — FACTS
- K982243 — CANOGEN PORTABLE OXYGEN GENERATOR MODEL 615
- K982544 — RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES
- K982937 — MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER
- K982941 — HEM-O-LOK MODEL NUMBERS 523900, 523970
- K982944 — HEM-O-LOCK, MODEL 523935
- K983064 — IMPRA HIGH POROSITY GRAFT
- K983282 — OMI OCCIPITAL CERVICAL LOOP, MODEL A1089
- K981199 — MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN
- K982315 — PROSPECT CAMPYLOBACTER MICROPLATE ASSAY
- K982362 — ABBOTT TESTPACK PLUS H. PYLORI
- K982431 — NMT SAFETY SYRINGE
- K982657 — AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100
- K982745 — AUTO-LYTE BARBITURATES EIA
- K982946 — PAINBUSTER INFUSION KIT
- K983049 — AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTER
- K983051 — AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
- K983087 — BREATHTIQUE TONGUE SCRAPER
- K983090 — ACON MIDSTREAM PREGNANCY TEST
- K983113 — BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT
- K983168 — AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S AVANT HS 100 & AVANT HS 200
- K983174 — ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES
- K983188 — DBEST TETRAHYDROCANNABINOL TEST KIT
- K983189 — DBEST METHAMPHETAMINES TEST KIT
- K983190 — DBEST OPIATES TEST KIT
- K983191 — DBEST COCAINE TEST KIT
- K983212 — ABBOTT ARCHITECT TESTOSTERONE
- K983262 — FRACTURE RISK ASSESSMENT OPTION FOR PIXI BONE DENSITOMETERS
- K983268 — MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY
- K983269 — FRACTURE RISK ASSESSMENT OPTION FOR EXPERT-XL BONE DENSITOMETER
- K983271 — FRACTURE RISK ASSESSMENT OPTION FOR DPX SERIES BONE DENSITOMETERS
- K983358 — G/K SFN AND STN LOCKING NAILS
- K983370 — PRODIGY- 3
- K983376 — THE APTUS (AUTOMATED) APPLICATON OF THE ENA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR S
- K983378 — THE APTUS (AUTOMATED) APPLICATION OF THE ANA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR.
Data sourced from openFDA. This site is unofficial and independent of the FDA.