FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
135313–135336 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 14, 1988
MODEL 3000 NUCLEAR CAMERA
K882312 · IYX
Ohio Imaging, Inc.
Radiology · 41d
Cleared Jul 14, 1988
ABBOTT TESTPACK(TM) CHLAMYDIA POSITIVE CONTROL
K882535 · LJC
Abbott Laboratories
Microbiology · 23d
Cleared Jul 14, 1988
LATEX EXAM GLOVES, NON-STERILE
K882583 · FMC
B Und J Instruments
General Hospital · 22d
Cleared Jul 13, 1988
DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM
K880322 · KMH
Dentronix, Inc.
General Hospital · 168d
Cleared Jul 13, 1988
CLINICAL ELECTONIC THERMOMETERS
K881368 · FLL
Sheridan Catheter Corp.
General Hospital · 22d
Cleared Jul 13, 1988
CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)
K881636 · EXB
Coloplast A/S
Gastroenterology & Urology · 90d
Cleared Jul 13, 1988
MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM
K881705 · INX
Surgi-Med, Inc.
Physical Medicine · 85d
Cleared Jul 13, 1988
ENTERAL FEEDING TUBES
K881978 · KNT
Primrose Medical, Inc.
Gastroenterology & Urology · 63d
Cleared Jul 13, 1988
POWER EXAMINATION TABLE
K882010 · LGX
Enochs Mfg., Inc.
General Hospital · 61d
Cleared Jul 13, 1988
CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM
K882092 · FNM
Gaymar Industries, Inc.
General Hospital · 55d
Cleared Jul 13, 1988
VITACUFF(R) PERCUTANEOUS INFECT. CONTROL KIT
K882100 · LJS
Vitaphore Corp.
General Hospital · 55d
Cleared Jul 13, 1988
MR. RAZOR II TWIN
K882388 · LDQ
Burney Products Corp.
General & Plastic Surgery · 33d
Cleared Jul 13, 1988
EXTENDED LIFE CAPD SOLUTION TRANSFER SET IC4373
K882455 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 29d
Cleared Jul 13, 1988
VAS-CATH PEDIATRIC HEMOFILTRATION CATHETER
K882466 · LFK
Vas-Cath, Inc.
Gastroenterology & Urology · 28d
Cleared Jul 13, 1988
EXTENDED LIFE CAPD TRANSFER SET 5C4444
K882498 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 26d
Cleared Jul 13, 1988
JEDMED/POLACK KERATOSCOPE HS/SL
K882618 · HLR
Gamut Ent.
Ophthalmic · 19d
Cleared Jul 12, 1988
ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.
K874253 · LNK
Minnesota Laser Corp.
Gastroenterology & Urology · 266d
Cleared Jul 12, 1988
ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.
K874255 · LNK
Minnesota Laser Corp.
Gastroenterology & Urology · 266d
Cleared Jul 12, 1988
PERIPHERAL VASCULAR LABORATORY ASSISTANT MODEL 101
K874938 · DSB
Sp Innovations, Inc.
Cardiovascular · 221d
Cleared Jul 12, 1988
HORIZON 2000 ARRHYTHMIA MONITORING OPTION
K881273 · DSI
Mennen Medical, Inc.
Cardiovascular · 109d
Cleared Jul 12, 1988
PROXIMA 1 PH MONITOR
K881706 · FFT
Technomanagement, Inc. C/O C.G.
Gastroenterology & Urology · 84d
Cleared Jul 12, 1988
SPECIAL PROCEDURES BASE UNIT MODEL 500
K881713 · FMT
Gempco, Inc.
General Hospital · 82d
Cleared Jul 12, 1988
MSI 4000 SERIES BED
K881782 · FNL
Med Service, Inc.
General Hospital · 77d
Cleared Jul 12, 1988
TRACER(TM) II BLOOD GLUCOSE SYSTEM
K881908 · CGA
Boehringer Mannheim Corp.
Chemistry · 67d