Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

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175,820 results
138577–138600 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 15, 1987
INTRA-ARTICULAR ARTHROSCOPIC SHAVER
K874044 · HWE
Medline Industries, Inc.
Orthopedic · 10d
Cleared Oct 14, 1987
STOMACH EVACULATOR - EWALD STYLE
K864963 · KOA
Medovations, Inc.
Gastroenterology & Urology · 296d
Cleared Oct 14, 1987
PLUS TOTAL KNEE SYSTEM, POLY PATELLAR BUTTON
K872134 · JWH
Orthomet, Inc.
Orthopedic · 133d
Cleared Oct 14, 1987
P. URINE METER, 250CC
K872824 · KNX
Ni-Med, Inc.
Gastroenterology & Urology · 90d
Cleared Oct 14, 1987
LASER OPTICAL FIBERS - DISPOSABLE
K872870 · LNK
Optimed Therapeutics
Gastroenterology & Urology · 86d
Cleared Oct 14, 1987
PARAGON 9000 TILT AND TURN BED
K872923 · FNL
Surgi-Med, Inc.
General Hospital · 79d
Cleared Oct 14, 1987
USI DENTAL POLISHER. A/G-20
K873147 · EFA
Cranston Ind., Inc.
Dental · 64d
Cleared Oct 14, 1987
HUFFMAN BIOPSY UNIT
K873176 · FCL
Penn Medical Devices, Inc.
Gastroenterology & Urology · 63d
Cleared Oct 14, 1987
DEVINE (SUPRAPUBIC SOUND AND GUIDE)
K873177 · KOE
Penn Medical Devices, Inc.
Gastroenterology & Urology · 63d
Cleared Oct 14, 1987
U-IMPULSE TVC AIR CONDUCTION HEARING AID
K873559 · ESD
Richards Medical Co., Inc.
Ear, Nose, Throat · 42d
Cleared Oct 14, 1987
MODIFIED RECTAL NOZZLE
K873948 · KPL
Colon Therapeutics
Gastroenterology & Urology · 16d
Cleared Oct 13, 1987
ODOR-SAFE(TM)(LIQUID) ODOR-SAFE(TM) POWDER
K871526 · EXB
Cox Family Laboratories, Inc.
Gastroenterology & Urology · 176d
Cleared Oct 13, 1987
ISTAT SOFTWARE
K871931 · GWS
Neuroscience, Inc.
Neurology · 147d
Cleared Oct 13, 1987
CHURCHILL ALBUMIN IV ADMINISTRATION SET
K872124 · FPA
Churchill Corp.
General Hospital · 134d
Cleared Oct 13, 1987
DIALY-NATE SET & DIALY-NATE CATHETER
K872221 · FKO
Gesco Intl., Inc.
Gastroenterology & Urology · 126d
Cleared Oct 13, 1987
HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309
K872364 · FII
Travenol Laboratories, S.A.
Gastroenterology & Urology · 117d
Cleared Oct 13, 1987
4LYF OXYGEN CONCENTRATOR
K872534 · CAW
Airsep Corp.
Anesthesiology · 109d
Cleared Oct 13, 1987
IMSI/EASY FLOAT MATTRESS
K872876 · FOH
Intl. Management Services, Inc.
General Hospital · 84d
Cleared Oct 13, 1987
TRACH CARE START KIT
K873732 · BSY
Ballard Medical Products
Anesthesiology · 64d
Cleared Oct 13, 1987
ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER
K873773 · GEX
Hgm, Inc.
General & Plastic Surgery · 27d
Cleared Oct 13, 1987
INSPIREASE(R), DRUG DELIVERY SYSTEM
K873793 · CCQ
Key Pharmaceuticals, Inc.
Anesthesiology · 26d
Cleared Oct 13, 1987
ALBUMIN IN URINE
K873861 · DCF
Unipath , Ltd.
Immunology · 50d
Cleared Oct 13, 1987
APOLIPOPROTEIN A1
K873863 · MSJ
Unipath , Ltd.
Immunology · 50d
Cleared Oct 13, 1987
APOLIPOPROTEIN B
K873864 · MSJ
Unipath , Ltd.
Immunology · 50d