Phoenix Biomedical Corp.

Valley Forge, PA, US

Phoenix Biomedical Corp. appears in FDA device records in Valley Forge, PA. FDA records list 17 510(k) clearances between 1996-02-09 and 2008-08-12, no PMA records and no registered establishments. As of 2026-09-10, FDA records show 6 recalls for this company.

510(k) clearances: 17
PMA records: 0
Recall records: 6
Registered establishments: 0

FDA records under these names

2 names

FDA records resolved to Phoenix Biomedical Corp. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Vygon Neuro510(k), recall
Vygon Us, LLC510(k), recall

510(k) clearance history

FDA records hold 17 510(k) clearances for Phoenix Biomedical Corp. between 1996 and 2008. The busiest year on record is 2003, with 3. The most recent is 2008, with 1.

Clearances by year, as a table

510(k) clearance decisions for Phoenix Biomedical Corp., by decision year
Year	Clearances
1996	2
1997	1
1998	1
1999	2
2000	2
2002	1
2003	3
2004	3
2006	1
2008	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K081942	NEUROCATH AG	JXG	Substantially Equivalent	2008-08-12
K052475	VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS	LJS	Substantially Equivalent	2006-09-14
K033704	MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS	JXG	Substantially Equivalent	2004-05-27
K040707	PACKAGING TRAY AND COMPONENTS	FRG	Substantially Equivalent	2004-04-16
K033017	PHOENIX INFUSION CATHETER	JXG	Substantially Equivalent	2004-04-07
K030468	ACURA ELITE GRAVITY COMPENSATING RESERVOIR	JXG	Substantially Equivalent	2003-10-15
K024101	PHOENIX UNIVERSAL SHUNT SYSTEM	JXG	Substantially Equivalent	2003-01-27
K024040	ACCURA ELITE SHUNT SYSTEM	JXG	Substantially Equivalent	2003-01-27
K021644	PERF (OMMAYA STYLE) RESERVOIRS	JXG	Substantially Equivalent	2002-08-06
K002476	LUMBOPERITONEAL SHUNT SYSTEM	JXG	Substantially Equivalent	2000-11-09
K000514	RUMBAR DRAINAGE SYSTEM	JXG	Substantially Equivalent	2000-05-10
K991429	DIAMOND II VALVE	JXG	Substantially Equivalent	1999-05-19
K990256	CRX WORLD SHUNT	JXG	Substantially Equivalent	1999-04-01
K974096	CRX DIAMOND VALVE	JXG	Substantially Equivalent	1998-12-08
K962144	PHOENIX ETE TISSUE EXTENSION SYSTEM	MKY	Substantially Equivalent	1997-01-14
K960435	PHOENIX CRX VALVE	JXG	Substantially Equivalent	1996-08-27
K953128	SUTURE CORD	GAS	Substantially Equivalent for Some Indications	1996-02-09

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Initiated	Status
Z-0367-06	10 cm Scopable Catheter Reservoir	stylet in package is shorter than that claimed on the label	2005-03-24	Terminated
Z-0366-06	7 cm Catheter Reservoir with 10 cm extension	stylet in package is shorter than that claimed on the label	2005-03-24	Terminated
Z-0365-06	6 cm Catheter Reservoir with 10 cm extension	stylet in package is shorter than that claimed on the label	2005-03-24	Terminated
Z-0585-04	Cruciform Slit Valve	mislabeled - product actually Single Valve	2004-01-06	Terminated
Z-0161-04	Reusable Catheter Passer (60 cm) SP02. One stainless steel catheter passer with T handle.	mislabeled as sterile	2003-09-09	Terminated
Z-0160-04	Reusable Catheter Passer (40 cm) SP01. One stainless steel catheter passer with T handle.	mislabeled as sterile	2003-09-09	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain