FDA 510(k) clearances — page 973
clearances on record, most recent first.
Clearances — page 973
97,201–97,300 of 176,637- K963356 — PHASED ARRAY SHOULDER COIL
- K963363 — HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS
- K963410 — POSEY STRAIGHT JACKETS
- K963414 — MULTIPLE BELTS
- K963421 — PROTECTIVE RESTRAINT (WAIST HOLDER)
- K963422 — PROTECTIVE RESTRAINT (PROTECTIVE MITT)
- K963430 — PROTECTIVE RESTRAINT (VEST RESTRAINT)
- K963436 — RESTRAINT ACCESSORIES
- K963442 — JACKETS AND VESTS
- K963485 — SILICONE RUBBER CUFF/DISPOSABLE FLEECE LINER'S WEB TORSO RESRAINT,NYON LIMB HOLDER,VINYL LIMB HOLDER,NYLON BED RESTRAINS
- K963552 — QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350)
- K963559 — WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010)
- K963564 — PERSONAL LIMB HOLDER (24444-200,300,24444-KIT)
- K963750 — RETRIEVAL SNARE
- K963778 — CDR-CAM
- K964278 — WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6
- K964565 — PARAMAX AMMONIA AND AMMONIA BLANK REAGENT
- K951226 — VITALMAX 4000/MINIPACK 3100/3000
- K954923 — BACTEC FUNGAL MEDIUM
- K960512 — GEMINI PC-ITX
- K961407 — SPEED-CUT
- K962128 — TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT)
- K962389 — EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE
- K963323 — ENDO VIP
- K963344 — DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE
- K963462 — COMFOR FOAM LIMB HOLDERS- SINGLE STRAP
- K963554 — 24448-010 SECURE-ALL FINGER CONTROL MITT
- K963556 — SECURE-ALL 1-PIECE BODY HOLDER, SMALL/MEDIUM (24451-010,020,24452-010,020,030)
- K963557 — SYSTEM 2 ZIPPERED BODY HOLDER, SMALL/MEDIUM 24453-010,24453-020,24453-030
- K963561 — ULTRA CARE VEST STYLE BODY HOLDER, SMALL (24455-010,020,030,040,24456-010,020,030,040)
- K963563 — ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145)
- K963577 — RADIONICS SLUIJTER-MEHTA CANNULA
- K963611 — VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH
- K963773 — 24457-010 SECURE ALL PELVIC HOLDER/24458-010 SECURE ALL BODY BELT
- K964062 — N PROTEIN STRANDARD SL
- K960315 — FLAVORED LATEX PATIENT EXAMINATION
- K961606 — METRO FOCAL ASPHERIC (POLYMACON)
- K961917 — MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX)
- K963010 — LIFESTYLE GP (TELEFOCON B) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENS FOR DAILY WEAR
- K963327 — TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610
- K963488 — SPECIALTY PROGRESSIVE(METHAFILCON A)MULTIFOCAL SOFT(HYDROPHILIC)CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED)
- K963742 — LATEX EXAMINATION GLOVES, POWDERED
- K963809 — COOL-ZONE
- K963840 — CEDIA PHENYTOIN II ASSAY
- K964063 — RDI LDL PRECIPITATION REAGENT
- K964064 — RDI LIPIDIRECT MAGNETIC LDL REAGENT
- K964466 — PALLADIA 75 (PM-11)
- K953742 — BIFURCATED Y-EXTENSION
- K954311 — KOH COLPOTOMIZER SYSTEM
- K955835 — FLUID BARRIER BOOT KNEE & ANKLE-HIGH
- K960630 — ANSPAHC SPEED REDUCER
- K960770 — MATCHMAKER/PROPAQUE PORCELAIN
- K961460 — LWEET CONE BIOPSY INSTRUMENT
- K961906 — UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10018
- K961999 — SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
- K962096 — MEDLINE, HYPOALLERGENIC, PRE-POWDERED NON-STERILE AND STERILE LATEX EXAMINATION GLOVES
- K962483 — MIDAS REX III MOTOR
- K962551 — CARDIOSERV S
- K962771 — BURKE CONGENITAL THORACOSCOPY INSTRUMENTS
- K962863 — KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR
- K963151 — MEDI-TRACE 5700 RESTING ECG ELECTRODE
- K963411 — POSEY LAPTOP TRAYS
- K963437 — PELVIC HOLDERS
- K963439 — PEDIATRIC LIMB HOLDERS
- K963484 — BARD HIGH FLOW PAPILLOTOME
- K963786 — TEMPFIL F
- K963890 — VARIOUS SUNGLASSES (NON-PRESCRIPTION)
- K963891 — RX 96E
- K963955 — DR. BERT'S SUNCARE PRODUCTS PEEPER KEEPERS
- K963968 — FLYWAY
- K964286 — ZOMED PASSIVE TEMPERATURE PROBE
- K955733 — HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED)
- K961566 — BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS
- K961588 — TOTAL IRON (NITRO-PAPS) REAGENT SET
- K962057 — ORGENTEC ANTI-RNP/SM ELISA
- K962062 — ORGENTEC ANTI-SM ELISA
- K963014 — SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM
- K963016 — SIMON NITINOL FILTER SYSTEM
- K963106 — CHROMOLIZE PAI-1 KIT
- K963132 — MINI STRIP/SERUM HCG
- K963133 — PS-UNIT CASSETTE/SERUM HCG
- K963245 — IMMULITE LATEX-SPECIFIC IGE
- K963258 — PEACOCK SYSTEM
- K964108 — FACT PLUS PREGNANCY TEST
- K955775 — SAFECONNECT VALVE (CATALOG NO. XXXX)
- K961333 — HEARTPORT MULTIFIRE CLIP APPLIER
- K961334 — HEARTPORT HANDSWITCH ELECTROCAUTERY PROBE
- K961509 — INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED
- K961665 — O BUTMENT ET IMPLANT
- K962052 — ORGENTEC ABTI-SS-BB(LA) ELISA
- K962053 — ORGENTEC ANTI-JO-1 ELISA
- K962054 — ORGENTEC ANTI-SS-A(RO) ELISA
- K962055 — ORGENTEC ANTI-SCL 70 ELISA
- K962825 — SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY
- K963038 — MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE
- K963226 — SURGICAL FABRICS
- K963236 — M & R DISPOSABLE ELECTRODE (14200)
- K963420 — CANCELLOUS SCREW WASHER
- K963453 — CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046)
- K963737 — HYCEM APLICAP
Data sourced from openFDA. This site is unofficial and independent of the FDA.