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
137209–137232 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 17, 1988
I.V. START KITS
K875315 · LRS
Ni-Med, Inc.
General & Plastic Surgery · 50d
Cleared Feb 17, 1988
UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM
K875354 · LCP
Ulster Scientific, Inc.
Hematology · 48d
Cleared Feb 17, 1988
THE BELTONE 2000 AUDIOMETER
K875360 · EWO
Beltone Electronics Corp.
Ear, Nose, Throat · 48d
Cleared Feb 17, 1988
MULTI-ALLERGEN IGE FAST SCREEN (MOLDS)
K880002 · DHB
3M Company
Immunology · 44d
Cleared Feb 17, 1988
ACROMED AWL/PUNCH, DEPTH GAUGE
K880045 · HWJ
Buckman Co., Inc.
Orthopedic · 42d
Cleared Feb 17, 1988
VOLZ TOTAL WRIST PROSTHESIS
K880156 · KWM
Biomet, Inc.
Orthopedic · 35d
Cleared Feb 17, 1988
MICRO-AIRE CEMENT REMOVAL TOOLS
K880324 · HSZ
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 22d
Cleared Feb 17, 1988
N-IMMUNOGLOBULIN LIGHT CHAIN KIT
K880341 · DFH
Behring Diagnostics, Inc.
Immunology · 22d
Cleared Feb 17, 1988
V-TREND IM DRY-SPOT TEST
K880399 · KTN
Texas Immunology, Inc.
Immunology · 19d
Cleared Feb 16, 1988
L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA
K874328 · JCF
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 117d
Cleared Feb 16, 1988
ADCOMP 4000 HP SYSTEM
K874495 · LHI
Healthtek, Inc.
General Hospital · 106d
Cleared Feb 16, 1988
FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101
K874623 · CDX
Cyberfluor, Inc.
Chemistry · 98d
Cleared Feb 16, 1988
STRATUM ESU
K874719 · JOS
Alternative Design Systems, Inc.
General & Plastic Surgery · 91d
Cleared Feb 16, 1988
TATUNG'S DENTURE CLEANING SOLUTION
K874805 · EFT
Tatung Company of America, Inc.
Dental · 85d
Cleared Feb 16, 1988
ABUSCREEN(R) EIA AMPHETAMINE
K874836 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 84d
Cleared Feb 16, 1988
RAMP HERPES SIMPLEX VIRUS (HSV) (CCT)
K874863 · GQN
Monoclonal Antibodies, Inc.
Microbiology · 83d
Cleared Feb 16, 1988
DISPOSABLE SYRINGE
K875097 · FMF
California Ent.
General Hospital · 68d
Cleared Feb 16, 1988
TECHNICON SMAC 3 SYSTEM
K875105 · JJC
Technicon Instruments Corp.
Chemistry · 64d
Cleared Feb 16, 1988
60 ML RESERVOIR BAG, ITEM #200
K875155 · KPE
Prn Services, Inc.
General Hospital · 63d
Cleared Feb 16, 1988
IV EXTENSION SET
K875186 · FPK
Marquette Medical, Inc.
General Hospital · 56d
Cleared Feb 16, 1988
STERILE SURGICAL NATURAL LATEX GLOVES
K875349 · KGO
Marand Products, Inc.
General Hospital · 47d
Cleared Feb 16, 1988
HASTING FINGER FIXATOR INSTRUMENTS
K880046 · HXY
Buckman Co., Inc.
Orthopedic · 41d
Cleared Feb 16, 1988
JMS TRANSFUSION SET
K880174 · BRZ
Jms Co., Ltd.
General Hospital · 32d
Cleared Feb 16, 1988
MOBILIMB HAND C.P.M. UNIT
K880336 · JFA
Toronto Medical Corp.
Physical Medicine · 21d