Johnson & Johnson MEDICAL GmbH

NORDERSTEDT Schleswig-Holstein, DE

Johnson & Johnson MEDICAL GmbH appears in FDA device records in NORDERSTEDT Schleswig-Holstein, DE. FDA records list 56 510(k) clearances between 1990-11-29 and 2004-10-21, one PMA record and one registered establishment. As of 2026-09-10, FDA records show no recalls for this company, and at least one establishment registration is current.

510(k) clearances: 56
PMA records: 1
Recall records: 0
Registered establishments: 1

510(k) clearance history

Showing 50 of 56

FDA records hold 56 510(k) clearances for Johnson & Johnson MEDICAL GmbH between 1990 and 2004. The busiest year on record is 1994, with 11. The most recent is 2004, with 1.

Clearances by year, as a table

510(k) clearance decisions for Johnson & Johnson MEDICAL GmbH, by decision year
Year	Clearances
1990	1
1991	3
1992	5
1993	5
1994	11
1995	9
1996	5
1997	7
1998	5
1999	1
2000	1
2002	1
2003	1
2004	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K033523	COLLAGEN-ORC ANTIMICROBIAL MATRIX	FRO	Substantially Equivalent	2004-10-21
K022483	ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING	FRO	Substantially Equivalent	2003-02-03
K014129	PROMOGRAN MATRIX WOUND DRESSING	KGN	Substantially Equivalent	2002-02-14
K001690	PROTECTIV SAFETY BLOOD COLLECTION NEEDLE	FMI	Substantially Equivalent	2000-07-31
K982641	ADVANCED NIBP MODULE	DXN	Substantially Equivalent	1999-03-29
K983362	NU-GEL * WOUND DRESSING	MGQ	Substantially Equivalent	1998-12-16
K982597	FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE	KGN	Substantially Equivalent	1998-08-20
K974080	CRITIKON SOFT BLOOD PRESSURE CUFF	DXQ	Substantially Equivalent	1998-05-18
K980493	I.V. CATHETER SYSTEM	FOZ	Substantially Equivalent	1998-04-28
K972498	OBSERVER * CENTRAL STATION	DSI	Substantially Equivalent	1998-02-17
K973699	ULTRALON POWDER FREE LATEX SURGICAL GLOVE	KGO	Substantially Equivalent	1997-12-16
K971569	DINAMAP MPS PORTABLE MONITOR	MSX	Substantially Equivalent	1997-09-19
K970182	DINAMAP COMPACT MONITOR	MHX	Substantially Equivalent	1997-08-18
K964556	HR POLYURETHANE PICC AND MIDLINE CATHETERS	LJS	Substantially Equivalent	1997-04-16
K970721	DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM	MCY	Substantially Equivalent for Some Indications	1997-03-21
K965040	INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL	HHW	Substantially Equivalent	1997-03-10
K962978	CCENTERMARK CATHETER INTRODUCER SHEALTH WITH PROTECTIV 2000 NEEDLE SAFETY SYSTEM	DYB	Substantially Equivalent	1997-01-07
K964016	TIELLE HYDROPOLYMER FOAM DRESSING	KMF	Substantially Equivalent for Some Indications	1996-12-31
K962226	PROTECTIV 2000 I.V. CATHETER SAFETY SYSTEM	FOZ	Substantially Equivalent	1996-12-23
K962986	MAXXUS POWDER FREE ORTHOPAEDIC LATEX SURGICAL GLOVES	KGO	Substantially Equivalent	1996-09-20
K955113	DINAMAP SELECT MULTI-PARAMETER SYSTEM	DPS	Substantially Equivalent	1996-08-15
K961632	MICRO-TOUCH POWDER FREE LATEX SURGICAL GLOVES	KGO	Substantially Equivalent	1996-07-03
K944587	DERMIVIEW HYPOALLERGENIC CLEAR TAPE	KGX	Substantially Equivalent	1995-10-30
K953655	J-VAC SUCTION RESERVOIRS & J-VAC BLAKE SILICONE DRAINS	OCX	Substantially Equivalent	1995-10-13
K953639	NEUTRALON BROWN LATEX SURGICAL GLOVES	KGO	Substantially Equivalent	1995-10-12
K954049	MICRO-TOUCH* LATEX SURGICAL GLOVES	KGO	Substantially Equivalent	1995-10-05
K953641	MAXXUS ORTHOPAEDIC SURGICAL GLOVES	KGO	Substantially Equivalent	1995-09-15
K933654	BLADDER NECK SUPPORT PROTHESIS FITTING KIT	HHW	Substantially Equivalent	1995-05-04
K930618	VAGINAL CONTINENCE DEVICE	HHW	Substantially Equivalent	1995-05-04
K945158	MICRO-TOUCH LP LATEX SURGICAL GLOVES	KGO	Substantially Equivalent	1995-02-13
K945157	MAXXUS LP ORTHOPAEDIC LATEX SURGICAL GLOVES	KGO	Substantially Equivalent	1995-02-13
K943900	LATEX MEDICAL GLOVE	LYY	Substantially Equivalent	1994-12-12
K943620	MICRO-TOUCH LATEX MEDICAL GLOVES	LYY	Substantially Equivalent	1994-09-09
K934608	BARRIER FABRIC 450 SURGICAL GOWN	FYA	Substantially Equivalent	1994-04-11
K932731	BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN	FYE	Substantially Equivalent	1994-04-11
K924434	CIDEX ACTIVATED DIALDEHYDE SOLUTION	LRJ	Substantially Equivalent	1994-03-29
K924334	CIDEX FORMULA 7* LONG-LIFE ACTIVATED DIALDEHYDE	MED	Substantially Equivalent	1994-03-29
K923744	CIDEX PLUS 28 DAY SOLUTION	LRJ	Substantially Equivalent	1994-03-29
K934194	BARRIER LASER PLUS FACE MASK	FXX	Substantially Equivalent	1994-03-28
K935227	MAXXUS ORTHOPAEDIC LATEX SURGICAL GLOVES	KGO	Substantially Equivalent	1994-03-07
K920108	BARRIER EXTRA PROTECTION PLUS FACE MASK	FXX	Substantially Equivalent	1994-02-10
K932336	NU-GEL ISLAND WOUND DRESSING	NAE	Substantially Equivalent	1994-02-09
K921910	STERRAD CHEMICAL INDICATOR	JOJ	Substantially Equivalent	1993-10-04
K921909	STERRAD BI TEST PACK	FRC	Substantially Equivalent	1993-10-01
K915682	STERRAD 100 STERILIZATION SYSTEM	FLF	Substantially Equivalent	1993-10-01
K925548	FIBRACOL COLLAGEN-ALGINATE DRESSING	FMF	Substantially Equivalent	1993-07-13
K923235	BIOCLUSIVE MVP TRANSPARENT DRESSING	KGX	Substantially Equivalent	1993-05-12
K915218	ULTRALON POWDERFREE SURGICAL GLOVES	KGO	Substantially Equivalent	1992-12-15
K921983	NU-BREDE PACKING AND DEBRIDEMENT SPONGE	EFQ	Substantially Equivalent	1992-09-18
K922895	J-VAC BULB SUCTION RESERVOIR	GCY	Substantially Equivalent	1992-09-15

Registered establishments

FDA registered establishments for Johnson & Johnson MEDICAL GmbH, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3002294946	3002294946	Johnson & Johnson MEDICAL GmbH	ROBERT-KOCH-STRASSE 1, NORDERSTEDT Schleswig-Holstein 22851 DE	2026	FHQ FTL GAM GDJ GXQ NEW NHB OTO OXC

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

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