FDA 510(k) clearances — page 1021
clearances on record, most recent first.
Clearances — page 1021
102,001–102,100 of 176,637- K953842 — SAS SALMONELLA H C ANTIGEN
- K953843 — SAS SALMONELLA O GROUP F ANTIGEN
- K953844 — SAS SALMONELLA VI ANTIGEN
- K953846 — SAS SALMONELLA O GROUP C ANTIGEN
- K953848 — SAS SALMONELLA O GROUP B ANTIGEN
- K953917 — LASESONICS LOW POWER CO2 LASER SYSTEM
- K954001 — SPETZLER PIN
- K954072 — MICROSURGE PUNCTURE CLOSE DEVICE
- K954197 — DISPOSABLE FLEX TUBE
- K954346 — CHEMSTRIP MICRAL URINE TEST STRIPS
- K954377 — FORCEPS, GRASPING, FLEXIBLE ENDOSCOPIC
- K945642 — AGEN DIMERTEST GOLD EIA
- K945838 — CTPORT CT SIMULATION SYSTEM FOR RADIOTHERAPY
- K950656 — PED ALERT
- K950709 — SYNERGY TI ANTERIOR SPINAL SYSTEM
- K951757 — DRIVING GLASSES
- K953482 — XKNIFE-3
- K953570 — PHILIPS MULTI LEAF PRESCRIPTION ENTRY SYSTEM (MLP)
- K953627 — NEW SUN OPTICAL NON PRESCRIPTION SUNGLASSES
- K953702 — WASHER
- K953710 — ELX808 AUTOMATED MICROPLATE READERS
- K953744 — AMITA CORPORATION VARIOUS MODELS OF SUNGLASSES
- K953808 — CHENG CHEN HSING NON-PRESCRIPTION SUNGLASSES
- K954000 — ROCHE REAGENT FOR BUN
- K954213 — ATH FULL PROFILE ACETABULAR CUP SYSTEM
- K954393 — SINCLAIR NON-PRESCRIPTION SUNGLASSES
- K954636 — BLINDE OPTICS
- K954639 — SUNGLASSES
- K941599 — MITEK ABSORBABLE ANCHOR
- K945854 — B-FACT, BORDERLINE FACTOR ASSAY CONTROL
- K945855 — A-FACT, ABNORMAL FACTOR ASSAY CONTROL
- K950004 — HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER
- K951919 — B-D PEN ULTRA
- K951977 — DIGITAL BLOOD PRESSURE METER - MODEL NO.: BPM883
- K952895 — CMS URETHRAL WARMER
- K953193 — SCINTRON IV
- K953255 — NUQUEST NUCLEAR MEDICINE COMPUTER
- K953400 — GUEDEL AIRWAY
- K953412 — CANDELA MODEL PLTL-1 LASER SYSTEM
- K953430 — ULTRASOUND PROBE BIOPSY ACCESSORIES
- K953483 — SIMS BLUE LINE ENDOBRONCHIAL TUBE
- K953503 — PRESSUREGUARD IV
- K953552 — SIENET SPI SPOOLER
- K953584 — LIFESHIELD LUER ACTIVATED VALVE MALE ADAPTER PLUG
- K953802 — TYMPANOSTOMY TUBE
- K954021 — EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II)
- K954055 — HDX DIGITAL IMAGING SYSTEM
- K954196 — UNIVERSIX 120
- K954521 — MAMMOSPOT PADDLE
- K952482 — KSEA REVERSE VIDEO
- K952897 — NIOMED SHOE COVERS
- K952937 — NIOMED NON-SKID SHOE COVERS
- K953032 — LUNAR DPX DENSITOMETER
- K953248 — IRIS BILATERAL TMJ
- K953377 — DISTENTION BALLOON
- K953664 — VITALOCK SPIKED ACETABULAR SHELL
- K953992 — LUMITROL CONTROLLER, LUMITROL HAND-CONTROLLED ELECTROSURGICAL PENCIL WITH BLADE ELECTRODE
- K954024 — CHEMSTRIP CRITERION URINE ANALYZER
- K954178 — OSOM PREGNANCY TEST
- K954187 — TRIGLYCERIDES REAGENT
- K954193 — SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET
- K954212 — CONTAMINATION CONTAINMENT DRAPE
- K954217 — ARTHROPLAST & ARTHRO-CUTTER
- K954251 — 5F ENVOY GUIDING CATHETER (MODIFICATION)
- K954414 — CENTRALITE BACKPOINTER
- K954435 — WILOMAT STERILIZABLE CLIP FORCEPS W/INTERCHANGABLE MAGAZINES
- K954458 — BOAT NOSE OBTURATOR
- K954459 — CONICAL OBTURATOR
- K954463 — DISSECTING OBTURATOR
- K954464 — CARPAL TUNNEL SLOTTED CANNULA
- K954475 — BLUNT DISSECTOR, CURVED
- K954476 — PROBE
- K954621 — RECLOSABLE WOUND COVER
- K954633 — CONMED ELECTROSURGICAL GROUNDING PAD
- K954693 — MEHTA BRONCHIAL BIOSPY DRILL
- K934866 — HYS-SURGIMAT
- K944689 — ZIRCONIA CERAMIC FEMORAL HEAD
- K945677 — IL682, CO-OXIMETER
- K945857 — PROTEIN C DEFICIENT PLASMA
- K946335 — OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES
- K951105 — KARL STORZ PRESSURE CUFF FOR USE WITH THE KSEA HYDROMAT PUMP
- K951542 — DIRECTIGEN 1-2-3 GROUP A STREP TEST
- K951820 — THROMBOPLASTIN-LI REAGENT
- K952178 — PH-DETECT TEST
- K953264 — QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM
- K953437 — OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT
- K953472 — NELLCOR SYMPHONY N-3100 BLOOD PRESSURE MONITOR
- K953490 — TRILOGY ACETABULAR SHELL & LINERS 36MM
- K953638 — O.B. APPLICATOR TAMPONS
- K953772 — BREATHE RIGHT NASAL STRIP
- K953903 — LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MM
- K954194 — DISPOSABLE HME/FILTER
- K954257 — QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION)
- K954680 — ACCESS PROLACTIN ASSAY (MODIFICATION)
- K935454 — DPX TISSUE QUANTIFICATION OUTPUT
- K940003 — VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT
- K942651 — BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS
- K944595 — CORDIS HORIZONTAL-VERICAL VALVE SYSTEM
- K945775 — BOEHRINGER AUTOVAC(R) 7900 SERIES
- K950566 — DECOMAT 4656
Data sourced from openFDA. This site is unofficial and independent of the FDA.