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
136609–136632 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 17, 1988
FLIPSCREEN QAT
K874802 · DHB
Alerchek, Inc.
Immunology · 86d
Cleared Feb 17, 1988
MIRACLE EAR MODEL BP BEHIND-THE-EAR HEARING AID
K874830 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 85d
Cleared Feb 17, 1988
ACUSON I7505 TRANSDUCER FOR INTRACAVITARY APPLICA.
K874860 · ITX
Acuson Computed Sonography
Radiology · 82d
Cleared Feb 17, 1988
MODEL 35300 TRACKER(TM) THERAPY BEAM EVALUATOR
K874893 · IYE
Keithley Instruments, Inc.
Radiology · 78d
Cleared Feb 17, 1988
MAT (TM) MICROALBUMIN TEST
K875161 · DCF
Wampole Laboratories
Immunology · 64d
Cleared Feb 17, 1988
PLUS TOTAL KNEE SYSTEM, POLY TIBIAL PEG
K875201 · JWH
Orthomet, Inc.
Orthopedic · 61d
Cleared Feb 17, 1988
DANNINGER ORTHOPAEDIC AWL
K875223 · HWJ
Danninger Medical Technology, Inc.
Orthopedic · 57d
Cleared Feb 17, 1988
GULLSORB IGG INACTIVATION REAGENT
K875254 · DEW
Gull Laboratories, Inc.
Immunology · 57d
Cleared Feb 17, 1988
TOTAL IGE IMMUNO RESPONSE TEST (IRT(R))
K875274 · DHB
Incstar Corp.
Immunology · 55d
Cleared Feb 17, 1988
QM300 CALIBRATOR B PACK
K875282 · JIX
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 55d
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