Davol, Inc.
Davol, Inc. holds FDA 510(k) medical device clearances, first cleared 1977, most recent 2025, with 8 FDA device recalls on record.
Top product codes for Davol, Inc.
FDA recalls by Davol, Inc.
- Z-1896-2026 — Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
- Z-2243-2023 — Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450G (EU only)
- Z-2242-2023 — Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450
- Z-2241-2023 — Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460
- Z-2244-2023 — Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955460G (EU Only)
- Z-1457-2022 — X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)
- Z-1304-2022 — HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction and Irrigation Tubing, Catalog number 0026880
- Z-1305-2022 — HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irrigation Tubing, Catalog Number 0026870
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Davol, Inc.
- K251557 — Bard® Mesh; Bard® Mesh Pre-Shaped
- K250098 — Bard Soft Mesh; Bard Soft Mesh Pre-Shaped
- K031213 — AQUASENS FLUID MONITORING SYSTEM
- K030307 — DAVOL ARTHROVENT OUTFLOW TUBING
- K003323 — COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205
- K003790 — DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005
- K931899 — DAVOL ATS
- K941334 — DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE
- K921405 — DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP
- K935503 — DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET
- K926479 — BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM
- K931552 — DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT
- K932327 — THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM
- K930147 — SURGICAL MESH DELIVERY SYSTEM, GENERAL SURGERY
- K924144 — ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (CTR)
- K924592 — DAVOL KNOT PUSHER
- K914119 — DAVOL ORTHOPAEDIC AUTOTRANSFUSION SYSTEM
- K921755 — 8 FR SINGLE LUMEN HIGH PERF. GROSHONG CENT. VENOUS
- K922526 — DAVOL LAPAROSCOPIC LOOP AND RETRIEVAL DEVICES
- K920659 — DAVOL ENDO-FLO LASER PROBE AND ACCESSORIES
- K914755 — DAVOL LAPAROSCOPIC CHOLANGIOGRAM CATHETER & KIT
- K915536 — DAVOL 100CC SILICONE CLOSED WOUND DRAINAGE EVAC
- K915406 — DAVOL ELECTROSUGICAL PROBES
- K914910 — DAVOL LAPAROSCOPIC INSTRUMENTS (GEN SURG REUSABLE)
- K914526 — DAVOL ENDO-FLO SUCT/IRRI PROBE (FOR GEN SURGERY)
- K913684 — DAVOL POST-OP AUTOTRANSFUSION SYSTEM
- K913235 — DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH
- K913028 — ARTHRO-FLOW IRRIGATION 2 SYSTEM
- K912702 — PLASTIC ATTACHABLE DUAL PORT
- K911205 — ARTHROSCOPY INSTRUMENT CANNULA
- K910486 — 8 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER
- K905448 — THORA-KLEX CHEST DRAINAGE UNIT
- K910340 — LAPAROSCOPIC ASPIRATION PROBE
- K904558 — DUAL LUMEN 5 FR PERIP CENT VEN CATH W/GROSHONG VAL
- K905016 — PEDIATRIC AND INFANT CATH KITS
- K902722 — BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM
- K901401 — DAVOL AUTOTRANSFUSION BLOOD PROCESSING SYSTEM
- K903530 — PERCUTANEOUS INTRODUCERS
- K896127 — THORA-KLEX CHEST DRAINAGE UNIT
- K894990 — DAVOL ARTHROSCOPY CANNULA
- K800081 — DAVOL/ABAMSON SILICONE SUMP DRAIN
- K792332 — DAVOL/SIMON DERMATOME
- K792281 — USHER'S MARLEX TUBULAR MESH
- K791306 — ELLIK EVACUATOR
- K791137 — SINGLE USE MONOPOLAR HAND CONTROL PENCIL
- K782027 — HYSTERECTOMY T DRAIN
- K782028 — ROUND SILICONE DRAIN
- K782026 — FLAT SILICONE DRAIN
- K780724 — BUBBLE SUCTION TUBING
- K772292 — T-TUBE WHELAN-MOSS
Data sourced from openFDA. This site is unofficial and independent of the FDA.