Atlas FDA

LGF

31 FDA 510(k) clearances · Product code

28 daysmedian time to decision
126 days90th percentile
31clearances measured

FDA profile

Official device name
Component, Cast
Device class
Class I (low risk)
Regulation
21 CFR 888.5940
Medical specialty
Orthopedic
Flags
GMP exempt
Adverse events (MAUDE)
1993: 1 · 1994: 1 · 1996: 1 · 1999: 2 · 2000: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC (K043526)Noble Fiber Technologies, Inc.2005-03-10
CLINITEX CAST PADDING (K973420)Clinitex Medical Corp.1997-12-09
CLINITEX STOCKINETTE (K973417)Clinitex Medical Corp.1997-12-09
PROTEC COTTON PADDING BANDAGE (K955320)Derivadas Degasa S.A. DE C.V.1996-01-26
QUICK-CAST IMMOBILIZER (K932507)Landec Corp.1994-02-23
CARAPACE STERILE CAST PADDING (K931672)Carapace, Inc.1993-12-15
ARTIFLEX(TM) (K910274)Beiersdorf, Inc.1991-03-05
COOL CAST(R) (K903946)Hawthorne Products, Inc.1990-12-31
CARAGLAS XTRA SYNTHETIC CASTING TAPE (K896634)Buckman Co., Inc.1990-06-14
SYNTHETIC CAST TAPE (K883294)Carapace, Inc.1988-08-30
COLORED CASTING TAPE CARAGLAS(TM GREEN (K874880)Synthetic Mfg., Inc.1987-12-30
PEDESTAL WALKING HEEL PRODUCT NO. 4183-133 (K873722)Martin Medical1987-10-02
CHILD WALKING HEEL PRODUCT NO. 4183-132 (K873718)Martin Medical1987-10-02
CUSHION TREAD WALKING HEEL PRODUCT NO. 4183-135 (K873717)Martin Medical1987-10-02
COLORED CASTING TAPE (RED AND BLUE) (K870404)Buckman Co., Inc.1987-02-13
OEC DESIGN ORTHOPEDIC CAST HEEL (K864092)Military Engineering, Inc.1986-12-16
AMERICAN ORTHOPAEDIC CAST CUTTER, MODEL 0295-202 (K861075)Martin Medical1986-03-28
AMERICAN ORTHOPAEDIC VACUUM 0295-250 (K861073)Martin Medical1986-03-28
AMERICAN ORTHOPAEDIC CAST CUTTER, MODEL 0295-200 (K861074)Martin Medical1986-03-28
DELTA-LITE CASTING RESIN (K854554)Johnson & Johnson Professionals, Inc.1985-12-11
DELTA-LITE CASTING RESIN (K854341)Johnson & Johnson Professionals, Inc.1985-11-22
VENT-A-CAST (K843780)Orthopedic Technology, Inc.1984-11-14
MASTERFOOT CAST HEEL (K840617)Seton Products, Inc.1984-03-23
MASTERHINGE (K833084)Mark One Healthcare Products1983-10-14
CAST TOE COVER (K823819)Danek Medical, Inc.1983-01-14
WALKING HEEL (K823394)Orthopedic Systems, Inc.1982-12-03
SHOW'RBAG (K822059)The Healthcare Group Laboratories, Inc.1982-07-22
STERILE ORTHOPEDIC STOCKINETTE (K812904)Alba Health Care1982-01-18
COBBLER'S CHIP SPLINTS (K810110)Secol Co.1981-01-26
CONPHAR CAST HEELS (K803141)Conphar, Inc.1981-01-09
INSERTER, PLUG, BONE, LIDGE (K780283)Depuy, Inc.1978-03-17

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Every clearance here is in the API, with alerts when new ones post.