FDA 510(k) clearances — page 838
clearances on record, most recent first.
Clearances — page 838
83,701–83,800 of 175,890- K000005 — IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6
- K000012 — IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5
- K000076 — CELL-CHEX
- K000197 — CORTEK CYSTOSCOPE
- K000200 — CORTEK URETHEROSCOPE
- K000602 — PROTEGE WHEELCHAIR
- K993081 — IO-DRIVE
- K993557 — AUTOSTAT II RHEUMATOID FACTOR IGA ELISA
- K993604 — ENDOSCOPIC ANTI FOG DEVICE
- K993957 — DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR
- K994057 — SLENDAIR 4000 COMPRESSION SYSTEM
- K994125 — BAUSCH & LOMB 2-WEEK (HILAFILCON B) VISIBILITY TINTED CONTACT LENSES
- K994341 — FIBRINOGEN CALIBRATOR KIT
- K994348 — KSEA SCB-RUI
- K994374 — SOAKER CATHETER
- K994429 — VENUSA, LTD. EXTENSION SET WITH FILTER
- K000175 — HARDYDISK TICARILLIN 75MCG
- K000181 — HARDYDISK, CARBENICILLIN, 100MCG
- K000226 — DISPOSABLE POWDER FREE NITRILE EXAM GLOVES, WHITE COLOR
- K000231 — TRIAGE BNP CALIBRATION VERIFICATION CONTROLS
- K000378 — BACT/ALERT MB CULTURE BOTTLE
- K000387 — TERUMO NEEDLE WITH LOCKING SHEATH
- K993117 — SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN CONTENT 50 MCG OR LESS, FOR USE WITH CHEMOTHERAPEUTIC AG
- K993170 — MEDLINE BREATHABLE, IMPERVIOUS DISPOSABLE SURGICAL GOWNS
- K993610 — CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250
- K993811 — MULTISAFE POWDERED LATEX EXAMINATION GLOVES, NONSTERILE
- K993941 — UBAS
- K994144 — TOOTHBRUSH WASH
- K994170 — HYLASHIELD CL
- K994180 — PULPDENT CAVITY PREPARATION III
- K994282 — MRI- FLOW ANALYTICAL SOFTWARE PACKAGE
- K994328 — SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX
- K000011 — MODIFIED HYDROPHILIC COATED GUIDEWIRE
- K000073 — MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA
- K000276 — MPT 24 AND VITAL VIEW 24
- K000279 — STAPLETAC2 BONE ANCHOR SYSTEM
- K000343 — NAC Y-ADP
- K000477 — MDI DS-DNA TEST
- K000499 — ADVANTA SUPER SOFT GRAFT
- K000504 — ADVANTA SUPER SOFT GRAFT
- K000533 — VOCOM IMPLANT- 8MM
- K990330 — CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ
- K991684 — CHILLBUSTER PORTABLE ELECTRIC BLANKET SYSTEM, MODEL 8001
- K992524 — PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES AND LEADWIRES
- K992934 — LEMAITRE VENOUS THROMBECTOMY CATHETER
- K993189 — CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING
- K993694 — MIKRO-TIP ANGIOGRAPHIC CATHETER
- K994079 — REFLEX TREATMENT SYSTEM
- K994087 — SUPERSTITCH
- K994097 — MEDAMICUS EPIDURAL INTRODUCER
- K994151 — PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES
- K994232 — PHALANGEAL FIXATION SYSTEM
- K994291 — DIMENSION SPECIAL PROTEIN CALIBRATOR
- K994293 — DIMENSION C4 FLEX REAGENT CARTRIDGE
- K994296 — DIMENSION C3 FLEX REAGENT CARTRIDGE
- K994417 — OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING
- DEN000004 — QUICKAIR CHOKE RELIEVER, MODEL 59-001A
- K000071 — SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
- K000130 — HARDYDISK, NALIDIXIC ACID, 30MCG
- K000152 — KIPPMED I.V. MANIFOLD
- K000173 — CEMENT IT! UNIVERSAL C&B
- K000182 — HARDYDISK TOBRAMYCIN, 10MCG
- K000201 — HARDYDISK, STREPTOMYCIN 10MCG
- K000230 — TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS
- K000367 — SECURMIX
- K000394 — CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT
- K981567 — HYBRID CAPTURE II CT/GC TEST
- K992937 — DENTAL IMPLANT
- K994181 — PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE
- K994205 — MODIFICATION OF REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM
- K000006 — IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6
- K000007 — IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6
- K000183 — HARDYDISK, PIPERACILLIN, 100MCG
- K000318 — BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
- K000409 — MODIFICATION TO T-REX BIOPSY FORCEPS
- K991333 — MEDI-CULT SPERM FREEZE MEDIUM
- K991335 — MEDI-CULT FREEZING & THAWING PACKS
- K992147 — TRIPLE-FIX SPINAL FIXATION SYSTEM
- K992715 — NEURO URODYNAMIC SUITE, MODEL 9032E0101
- K993036 — ZOLL M SERIES ETCO2 OPTION
- K993401 — DRYSPOT E.COLI 0157 KIT
- K994217 — BLACKSTONE SPINAL FIXATION SYSTEM
- K994327 — EMBRYON TRANSFER CATHETERS/SETS
- K000232 — ROTAGLIDE + MODULAR KNEE SYSTEM WITH FIXED MENISCUS
- K000319 — EBI XFIX DFS SYSTEM
- K000335 — MALLORY-HEAD MODULAR CALCAR TOTAL HIP SYSTEM
- K000430 — AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511
- K980951 — ONEFLOW
- K991329 — MEDI-CULT PVP MEDIUM, MEDI-CULT PVP CLINICAL GRADE
- K991330 — MEDI-CULT LIQUID PARAFFIN
- K991351 — OVOIL-150, MODEL 5002
- K992220 — RADIAL HEAD PROSTHESIS
- K993017 — PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE
- K993515 — MEDEFIL'S NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE L
- K993714 — MEMOGRAPH STAPLE, WARM SYSTEM
- K994044 — CLEEN-ABLE
- K994153 — CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS
- K994202 — ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEM
- K994229 — VERIPATH PERIPHERAL GUIDING CATHETER
- K000034 — OIS-STAND ALONE DIAGNOSTIC ULTRASOUND SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.