FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
136273–136296 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 14, 1988
GOLDEN POWER LIFT CHAIR
K880800 · INO
Golden Technologies, Inc.
Physical Medicine · 14d
Cleared Mar 14, 1988
MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEM
K880826 · KYK
Johnson & Johnson Professionals, Inc.
Orthopedic · 13d
Cleared Mar 14, 1988
URESIL WOUND DRAIN TROCAR
K880895 · GBS
Uresil Corp.
General & Plastic Surgery · 12d
Cleared Mar 14, 1988
MECHANICAL WALKER
K880986 · INM
Canhart Industries, Inc.
Physical Medicine · 6d
Cleared Mar 11, 1988
PDS, MODEL NST 40 FETAL MONITOR, RECORDER & TRANS.
K873150 · HFM
Pediatric Diagnostic Service
Obstetrics & Gynecology · 213d
Cleared Mar 11, 1988
RNP ANTIBODY TEST KIT
K874152 · LKO
Lipogen, Inc.
Immunology · 150d
Cleared Mar 11, 1988
LA ANTIBODY TEST KIT
K874195 · LJM
Lipogen, Inc.
Immunology · 149d
Cleared Mar 11, 1988
ENVICLUSIVE (TM)
K874554 · NAD
Marion Laboratories, Inc.
General & Plastic Surgery · 128d
Cleared Mar 11, 1988
HEALTHPHONE TOCO MODEL
K874631 · HFM
Carelink
Obstetrics & Gynecology · 122d
Cleared Mar 11, 1988
OBT STEREOTACTIC SYSTEM
K874693 · HAW
Tipal Instruments , Ltd.
Neurology · 127d
Cleared Mar 11, 1988
GUARDALL SHIELD
K875008 · FXX
Anago, Inc.
General Hospital · 98d
Cleared Mar 11, 1988
ADDITIONAL ALLERGENS FOR IGE FAST-PLUS TEST
K880003 · DHB
Em Diagnostic Systems, Inc.
Immunology · 67d
Cleared Mar 11, 1988
REVISED LABELING FOR ADX COCAINE METABOLITE
K880009 · DIO
Abbott Laboratories
Toxicology · 67d
Cleared Mar 11, 1988
YESNG MODEL 200S11 ELECTROSURGICAL UNIT
K880064 · GEI
Ferguson Medical
General & Plastic Surgery · 64d
Cleared Mar 11, 1988
YESNG MODEL 500SII ELECTROSURGICAL UNIT
K880073 · GEI
Ferguson Medical
General & Plastic Surgery · 60d
Cleared Mar 11, 1988
MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA.
K880172 · LKW
Cooper Lasersonics, Inc.
Neurology · 56d
Cleared Mar 11, 1988
POLYDERM WBC (TM), WATERPROOF BREATHABLE COVER
K880206 · NAD
Laivan Corp.
General & Plastic Surgery · 56d
Cleared Mar 11, 1988
BLAKEMORE RETAINER
K880253 · FEF
Orthopedic Systems, Inc.
Gastroenterology & Urology · 51d
Cleared Mar 11, 1988
DISP. NON-MAGNETIC SURGICAL INSTRU. DRAPE
K880513 · KKX
Taub Industries
General Hospital · 31d
Cleared Mar 11, 1988
COHERENT XA-40 CO2 SURGICAL LASER
K880603 · GEX
Coherent Medical Group
General & Plastic Surgery · 28d
Cleared Mar 11, 1988
TECNOL FLUID SHIELD SURGICAL MASK W/EYEGUARD
K880757 · FXX
Tecnol New Jersey Wound Care, Inc.
General Hospital · 15d
Cleared Mar 11, 1988
SKILCRAFT
K880785 · KDD
Pennsylvania Association For the Blind
General & Plastic Surgery · 14d
Cleared Mar 11, 1988
SPINAL NEEDLE
K880812 · GDM
T. Korossurgical Instruments Corp.
General & Plastic Surgery · 14d
Cleared Mar 11, 1988
SELF-RETAINING SOFT TISSUE RETRACTOR
K880813 · GAD
T. Korossurgical Instruments Corp.
General & Plastic Surgery · 14d