FDA 510(k) clearances — page 1277
clearances on record, most recent first.
Clearances — page 1277
127,601–127,700 of 175,890- K900906 — FACTOR II DEFICIENT PLASMA
- K893006 — EXMOOR BITE BUFFER
- K894259 — REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULA
- K895114 — FRANK MILK PUMP
- K895225 — GYNECOLOGICAL INSTRUMENTATION
- K895368 — IN THE EAR HEARING AID
- K895449 — ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM
- K896909 — MD5 AUTOMATIC AUDIOMETER
- K896917 — HYSTEROSCOPE
- K896928 — FILPOST
- K893852 — COULTER CLONE T4 MONOCLONAL ANTIBODY
- K893853 — COULTER CLONE T8 MONOCLONAL ANTIBODY
- K896081 — WHITESIDE ORTHOLOC MODULAR METAL-BACKED PATELLA
- K896826 — SULTAN PERIO-SELECT IRRIGATION SYSTEM
- K896914 — IVAC MODEL 2090 INFRA RED THERMOMETER
- K897134 — CMW CEMENT PRESSURISATION SYSTEM
- K900005 — DEXTROLYTE II, MANUAL ADMINISTRATION SET 48-1032-1
- K900124 — APOLIPOPROTEIN B (APO B)
- K900674 — CONSTI-SSAGE VIBRATOR/MASSAGE
- K900794 — MOBILIMB H3 HAND CPM UNIT
- K896465 — CLP CK/LD ISOENZYME/IMMUNO CONTROL
- K896583 — F.A.S.T. TABLE
- K896794 — SPECIMEN CONTAINER
- K896924 — SPIROSCAN 4000
- K896991 — ENZYMUN TEST(R) TBK
- K897128 — UMI BRAIDED CATHETER CONNECTOR
- K897158 — ABBOTT COMMANDER PARALLEL PROCESSING CENTER
- K897161 — COULTER URIC ACID REAGENT
- K900147 — MODIFIED DSL-2300 ACTH RIA
- K900224 — STAT FAX(TM)-2100
- K900250 — AMRESCO ALKALINE PHOSPHATASE REAGENTS 7780 & 7781
- K900266 — STERILE CARBON STEEL SURGICAL BLADE
- K900300 — LYTENING 2Z LYTENING SYSTEM 31
- K900310 — REPEL SURGICAL GLOVE LINERS
- K900392 — CENTERING PLUG
- K900405 — SCHOLTEN FRAME
- K900420 — BICARBONATE REAGENTS PRODUCT #7713 & #7714
- K900621 — FIAGEN(TM) HLH.S
- K900656 — SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECT.
- K885046 — INSITUCAT VALVE STRIPPER
- K890182 — PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV
- K893221 — MODEL 8500 HAND HELD PULSE OXIMETER
- K893711 — DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR
- K894826 — UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF
- K895179 — ACCESSOR PERIPHERAL DILATING GUIDE WIRE
- K895511 — CATHETER BALLOON DILATOR PRESSURE GAUGE
- K895776 — AIV SYSTEMS' IV POLES
- K896039 — KING OF HEARTS 1200 MONITOR
- K896735 — TYPE 9290 INTERFACE RESPIRATOR
- K896736 — TYPE 9291 INTERFACE RESPIRATOR
- K896737 — TYPE 9292 INTERFACE CAPNOGRAPH
- K896741 — SCHNEIDER MONORAIL-PMC PRESSURE MONITORING CATH.
- K896849 — ACS INDEFLATOR XX
- K896978 — CLOSED CHEST SUPPORT CIRCUIT W/BIO-ACTIVE SURFACE
- K897084 — CONFEES(R)+ CONTACT LENS HOLDER
- K897085 — COMFEES(R) + CON-PAK(TM) LENS CASE
- K900282 — NEEDLE-SHIELD
- K900387 — DISCO SUNGLASSES (NON-PRESCRIPTION)
- K900426 — IV BIFURCATED EXTENSION SET
- K900427 — IV TRIFURCATED EXTENSION SET
- K890019 — LATEX SURGICAL GLOVES
- K894248 — CONVERTER SYSTEM
- K895411 — OPTIKEM PMMA CONTACT LENS
- K896193 — TECNOL LAZER(TM) SURGICAL MASK
- K896232 — COBAS READY TOTAL BILIRUBIN REAGENT
- K896235 — COBAS READY ALBUMIN REAGENT
- K896236 — COBAS READY BUN REAGENT
- K896355 — CMV IGM ELISA TEST SYSTEM
- K896676 — KEY VASCULAR LOOPS
- K896777 — RMI AORTIC ROOT PRESSURE MONITOR EXTENSION LINE
- K896778 — RMI VASOPLEGIA CANNULA WITH & WITHOUT CHECK VALVE
- K896956 — QUICK DISCONNECT CLAMP CATALOG NO. 48-0300-3
- K897110 — SATELLITE K+ BLOOD POTASSIUM MONITORING SYSTEM
- K900004 — CONVERTIBLE ADAPTER CATALOG NO. 48-4039-3
- K900006 — CATHETER ADAPTER SEALING CAP NO. 48-1028-9
- K900129 — MODIFIED AUTO SUTURE ENDOSCOPIC GIA SURG. STAPLER*
- K900259 — DIRECT BILIRUBIN REAGENT
- K900384 — INFRAVIB MASSAGER - MODEL PR-1000
- K900419 — CRYOTRON-UL30
- K900422 — TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046
- K900514 — JYROCHAIR POWER WHEELCHAIR
- K900523 — MODEL F3 FLIP-UP SUNGLASSES W/ACRYLIC ORANGE COMP.
- K900525 — MODEL F 1 FLIP-UP SUNGLASSES W/POLYCARBONATE BLUE
- K900579 — AUTOREADER CALIBRATION TEST PLATE
- K895044 — DUAL GUIDE INTRODUCER CATHETER
- K895379 — LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES)
- K895688 — NOBLES-LAI ENGINEERING INFUSION PUMP
- K896005 — SMALL CATHETER INFLATOR
- K896097 — VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY
- K896373 — 1400 SERIES EVIDENCE COLLECTION KIT
- K896703 — TBD IONTOPHORESIS ELECTRODE
- K896726 — 4 SURE EXTERNAL MALE CATHETER
- K896740 — AXIAL AND OFFSET CROSSLINK PLATES
- K896761 — TRANSFER SET SEALING CAP, CAT. NO. 48-1027-1
- K896763 — CATHETER ADAPTER CO-PAK CATALOG NO. 48-0122-1
- K896764 — UNIVERSAL CONNECTOR CATALOG NO. 48-1025-5
- K896771 — EKG, ECG KENZ, ECG 302
- K896772 — EKG, ECG KENZ, ECG 303
- K896806 — CATHETER PLUG/PROTECTOR
- K896875 — POSITIVE AND NEGATIVE HCG SERUM CONTROLS
Data sourced from openFDA. This site is unofficial and independent of the FDA.