FDA 510(k) clearances — page 846
clearances on record, most recent first.
Clearances — page 846
84,501–84,600 of 176,637- 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
- K000056 — BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS
- K000220 — MA-300 ELECTROMYOGRAPHY SYSTEM
- K000316 — MERETEK UBT_LITE BREATH TEST FOR H. PYLORI
- K000572 — E.N.S.I. SYRINGE
- K991346 — PH-100, MODEL 2104
- K992638 — DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400
- K993514 — DEFINITE
- K994014 — ESC INTENSE PULSED LIGHT SYSTEMS: EPILIGHT AND MULTILIGHT
- K994033 — HORTMANN ECHOMASTER OAE ANALYZER
- K994369 — 7250 (MEGAS)
- K000002 — MAGNA 5000 PHASED ARRAY CTL SPINE COIL
- K000210 — MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT
- K000257 — IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6
- K000364 — ACCU-CHEK COMPLETE METER
- K000365 — ACCU-CHEK ADVANTAGE METER
- K992290 — EXEL INJECTION PLUG WITH CAP
- K993633 — SYNTHETIC VDRL ANTIGEN
- K994182 — PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE
- K994318 — VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
- K994324 — ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
- K994356 — IMMUNOCYT
- K994421 — SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION
- DEN990002 — KAVO DIAGNODENT
- K000166 — SYNTHETIC (WHITE) VINAL POWDERED PATIENT EXAMINATION GLOVES
- K000228 — ENTEC CONTROLLER, ENTEC PATIENT CABLE, FOOTSWITCH, POWERCORD, PLASMA WAND
- K991571 — 10 CURIE IRDIUM 192, CSN00100-192
- K992214 — OXYCON PRO
- K992461 — STEALTHSTATION TREATMENT GUIDANCE PLATFORM
- K992537 — PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED
- K992940 — LEMAITRE BALLOON CATHETER WITH IRRIGATION
- K993974 — SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR
- K993976 — PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR
- K993979 — MARSPO2, MODEL 2001
- K993990 — LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM
- K994021 — CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION
- K994228 — REMOTEIMAGE SYSTEM
- K994275 — SIMS PORTEX ANESTHESIA CATHETER
- K000055 — CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17
- K000070 — FLOCATH
- K000128 — HARDYDISK, CEFAZOLIN, 30MCG
- K000132 — ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8
- K000156 — SMART SHIELD NON-STERILE POWDER-FREE PEPPERMINT SCENTED GREEN LATEX EXAMINATION GLOVES
- K000174 — ACTION AF-1 WHEELCHAIR
- K000196 — ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316
- K000217 — ROYAL SHIELD NON-STERILE PURPLE (PINK/BLUE) COLORED POWDERED LATEX EXAM WITH PROTEIN LABELING CLAIM [<200 MCG OR LESS] W
- K000360 — RX G-UNIVERSAL
- K000362 — MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM
- K000363 — MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
- K983943 — MICROSTREP PLUS PANEL, LEVOFLOXACIN
- K991345 — ASP-100, MODEL 2100
- K992359 — MRS-TITAN
- K992445 — MED-GUARD SURGEON'S GOWN
- K992539 — PERCUGUARD
Data sourced from openFDA. This site is unofficial and independent of the FDA.