Atlas FDA

GDY

111 FDA 510(k) clearances · Product code

53 daysmedian time to decision
126 days90th percentile
111clearances measured

FDA profile

Official device name
Gauze/Sponge, Internal, X-Ray Detectable
Device class
Class I (low risk)
Regulation
21 CFR 878.4450
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2021: 134 · 2022: 226 · 2023: 98 · 2024: 114 · 2025: 115 · 2026: 58
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
ULTRACELL SUCTION SPONGE (K972634)Ultracell Medical Technologies, Inc.1997-12-17
CPR LAP SPONGES (K960236)Custom Pack Reliability1996-03-28
STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE (K955599)Stryker Corp.1996-02-22
PROTEC X-RAY DETECTABLE GAUZE SPONGE (K955322)Derivados DE Gasa, S.A. DE C.V.1995-12-19
KENSORB (K953830)Kentron Health Care, Inc.1995-10-03
ROSEBUD DISSECTOR (K953060)Medical Perspectives Corp.1995-09-14
CHERRY PIT DISSECTOR (K953087)Medical Perspectives Corp.1995-09-14
CYLINDRICAL SPONGE (K953057)Medical Perspectives Corp.1995-09-14
ROUND STICK SPONGES, FLAT STICK SPONGES (K953058)Medical Perspectives Corp.1995-09-14
TRIANGULAR SPONGES (K953088)Medical Perspectives Corp.1995-09-14
KITTNER DISSECTOR (K953059)Medical Perspectives Corp.1995-09-14
CHERRY DISSECTOR (K953062)Medical Perspectives Corp.1995-09-14
GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE) (K951911)Commercial Resources New Mexico, Ltd.1995-06-21
ULTRACELL ORTHOPEDIC SPONGES (K950372)Ultracell Medical Technologies, Inc.1995-04-17
ULTRACELL ORTHOPEDIC SPONGES (K950370)Ultracell Medical Technologies, Inc.1995-04-17
ULTRACELL ORTHOPEDIC SPONGES (K950373)Ultracell Medical Technologies, Inc.1995-04-17
ULTRACELL RETRACTOR COVERS (K950659)Ultracell Medical Technologies, Inc.1995-04-13
CHERRY DISSECTOR (K945335)Lorrex Health Products1994-12-28
CYLINDRICAL SPONGE (K945866)Lorrex Health Products1994-12-28
TRIANGULAR SPONGES (K945606)Lorrex Health Products1994-12-28
ROUND STICK SPONGES, FLAT STICK SPONGES (K945553)Lorrex Health Products1994-12-28
KITTNER DISSECTOR (K945333)Lorrex Health Products1994-12-28
GAUZE SPONGES (K944879)Clinical Resources, Inc.1994-12-23
OREX (K940764)Thantex Specialties, Inc.1994-12-19
OREX (12X12 X-RAY DETECTABLE) (K940767)Thantex Specialties, Inc.1994-12-19
OREX (18X18 X-RAY DETECTABLE) (K940766)Thantex Specialties, Inc.1994-12-19
PEANUT DISSECTOR (K945336)Lorrex Health Products1994-12-05
CHERRY PIT DISSECTOR (K945334)Lorrex Health Products1994-12-05
ROSEBUD DISSECTOR (K945332)Lorrex Health Products1994-12-05
SPONGE, LAPAROTOMY, VARIOUS SIZE (K940436)Shawnee Products, Inc.1994-07-26
LORREX GAUZE SPONGES, X-RAY DETECTABLE (K942366)Lorrex Health Products1994-05-27
LAP SPONGE PRODUCT LINE (K941344)Cush Medical Products1994-05-12
STERILE X-RAY DETECTABLE GAUZE SPONGES (K941522)Cush Medical Products1994-05-12
ISOLYSER (18X18 X-RAY DETECTABLE) (K940762)Thantex Specialties, Inc.1994-05-02
ISOLYSER (8X4 12 PLY X-RAY DETECTABLE) (K940763)Thantex Specialties, Inc.1994-05-02
ISOLYSER (X-RAY DETECTABLE) (K940756)Thantex Specialties, Inc.1994-05-02
ISOLYSER (4X18) X-RAY DETECTABLE (K940757)Thantex Specialties, Inc.1994-05-02
DUPAQUE SPONGE (K941217)Dumex Medical Surgical Products, Ltd.1994-04-21
STERILE LAPAROTOMY SPONGES (K934971)Medsurg Industries, Inc.1994-02-07
NEUROLOGICAL SPONGES (K935883)Mcneil Healthcare, Inc.1994-02-03
SURGICAL SPONGE X-RAY DETECTABLE (K935993)Mcneil Healthcare, Inc.1994-02-02
TONSIL SPONGES (K935882)Mcneil Healthcare, Inc.1994-01-31
X-RAY PACKING SPONGE (K935910)Mcneil Healthcare, Inc.1994-01-31
SPECIALTY SPONGES (K935881)Mcneil Healthcare, Inc.1994-01-31
TENCEL X-RAY DETECTABLE SPONGES/LAP PADS (K932846)Courtaulds Fibers, Inc.1993-12-09
STERILE GAUZE SPONGES X-RAY DETECTABLE (K922054)Team Mfg., Inc.1992-08-10
SURGICAL SPONGES (K920356)Ultracell Medical Technologies, Inc.1992-08-06
SPECIALTY SPONGES (K920355)Ultracell Medical Technologies, Inc.1992-08-06
LAP SPONGES, MODIFIED (K913303)Carwild Corp.1992-08-06
DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIED (K913302)Carwild Corp.1992-07-23
SUAN FLAT DISSECTOR SPONGES (K914082)Icn Pharmaceuticals, Inc.1991-11-27
SIMPEX INC. SURGICAL DRESSING (K913794)Simpex, Inc.1991-11-20
ICAN K DISSECTOR SPONGES (K914083)Icn Pharmaceuticals, Inc.1991-10-09
LAPAROTOMY SPONGES (K905135)American Healthcare Corp.1991-03-06
ADVANCE LAPAROTOMY SPONGE, LAP SPONGE (K903358)Advance Medical Designs, Inc.1990-11-29
X-RAY DETECTABLE GAUZE SPONGE (K895372)Keilei Intl., Inc.1989-11-03
MASCOT LAB SPONGE (K894984)Mascot, Inc.1989-09-05
QUALTEX NEUROLOK SURGICAL SPONGE (K884790)Deroyal Industries, Inc.1988-12-09
GAUZE SPONGE, X-RAY DETECTABLE (K882708)Bioseal1988-08-03
TONSIL SPONGE, X-RAY DETECTABLE, W/STRING (K882709)Bioseal1988-08-03
GAUZE PACKING, X-RAY DETECTABLE (K882707)Bioseal1988-08-03
MODIFIED ROUND (BEEHIVE) DISSECTOR 3/8 (K873391)Ormed Mfg., Inc.1987-09-11
NON-WOVEN TRACHEOTOMY SPONGE (K872807)American Silk Sutures, Inc.1987-08-04
GAUZE CHERRY SPONGE (K872809)American Silk Sutures, Inc.1987-08-04
LAPORATOMY SPONGES SIZES:18X18,12X12,4X18,8X36 (K864529)Elof Hansson, Inc.1986-12-16
DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000 (K863089)Lifestream Int'L, Inc.1986-10-14
X-RAY DETECTABLE COTTON BALLS (K854714)American Silk Sutures, Inc.1985-12-17
GAUZE SPONGE (K853742)South Mountain Medical1985-10-08
GAUZE & LAB SPONGES STERILE & NON (K842572)Ulti-Med Intl., Inc.1984-08-15
NEURO SPONGE (K840541)Surgicot, Inc.1984-04-23
FLORET FOAM PREP SPONGE (K833626)Ritmed, Inc.1984-02-17
STRUNG NEURO SPONGE PATTIES-X-RAY- (K831914)Ormed Mfg., Inc.1983-10-31
COLOR-EZE PRE-WASHED LAP SPONGES (K831913)Ormed Mfg., Inc.1983-09-26
GAUZE SPONGE X-RAY DETECTABLE- (K832172)Sudreca Surgical Dressings, Inc.1983-08-12
FLORET VAGINAL PACKING/TAMPONS (K830260)Ritmed, Inc.1983-03-17
ZANLEX, ZAN-TEX & ZANDEX (K830511)Winn Hirsch & Assoc.1983-03-17
POLYESTER X-RAY DETECTABLE STRUNG-SPONGE (K830201)American Medical Disposable, Inc.1983-02-23
COTTON BALLS, X-RAY OPAQUED STRUNG & NON (K830202)American Medical Disposable, Inc.1983-02-23
NO-GAUZE LAPAROTOMY SPONGE (K823671)Surgilite Intl., Inc.1983-01-09
LAPAROTOMY SPONGE (K822623)Hermitage Hospital Products, Inc.1982-10-13
PRE-PACK TENS (K813286)Cunningham Woodland, Inc.1982-01-22
PARKE-DAVIS AEGIS ABOSRBENT SPONGES (K813595)Deseret Medical, Inc.1982-01-18
NEUROSPONGE PADDIE (K812390)Winn Hirsch & Assoc.1981-11-24
NEUROSPONGES (K812391)Winn Hirsch & Assoc.1981-11-24
X-RAY DETECTABLE THREAD (K812018)Isramed, Inc.1981-11-20
X-RAY DETECTABLE BAND (K812017)Isramed, Inc.1981-11-20
SURGICAL DRESSINGS (K812831)Foreign Trade Zone of Wisconsin1981-11-06
STERILE LAPAROTOMY SPONGES-X-RAY DETECT (K812710)Medspec Corp.1981-11-02
STERILE DISSECTOR SPONGES-X-RAY DETECT (K812707)Medspec Corp.1981-11-02
X-RAY DETECTABLE LAP SPONGES (K812651)Procter & Gamble Mfg. Co.1981-10-20
TOMAC STERILE DISP. LAP SPONGE (K812554)American Convertors Div., American Pharmaseal1981-09-24
UNSTERILIZED LAPAROTOMY SPONGES (CHINA) (K811632)Robert I. Chien & Assoc., Inc.1981-09-11
LAPAROTOMY PADS (K811769)South Mountain Medical1981-08-07
LAPAROTOMY SPONGE (K810184)Medical Action Industries, Inc.1981-02-04
GAUZE SPONGES (K803188)Abco Dealers, Inc.1981-01-15
GAUZE, ABSORBABLE X-RAY DETECT. LAP SPG. (K802982)Stanford Laboratories1980-12-19
OPRATEX ABDOMINAL PAD (K802798)Secol Co.1980-12-11
STERILE TONSIL SPONGES (K802060)Medspec Corp.1980-10-10
CONTAIN X-RAY DETECTABLE LAP SPONGE (K801768)The Buckeye Cellulose Corp.1980-08-20
MEDSPEC PACKING GAUZE (K800281)Medspec Corp.1980-03-12
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