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

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175,820 results
114409–114432 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 11, 1993
VIDAS TOXO IG6 ASSAY (TX6)
K922737 · LGD
Biomerieux Vitek, Inc.
Microbiology · 337d
Cleared May 11, 1993
COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR
K923272 · DTZ
Cobe Laboratories, Inc.
Cardiovascular · 309d
Cleared May 11, 1993
MODEL 3500 MR-COMPATIBLE PULSE OXIMETER
K924285 · DQA
Magnetic Resonance Equipment Corp.
Anesthesiology · 259d
Cleared May 11, 1993
CLEARVIEW HCG
K924673 · JHI
Unipath , Ltd.
Chemistry · 237d
Cleared May 11, 1993
LIFE SHIELD HEALTHCARE PRODUCTS BREATHING FILTER
K925388 · CAH
Life Shield Healthcare Products, Inc.
General Hospital · 197d
Cleared May 11, 1993
SMART-SCREENER (AUDITORY)
K925648 · GWJ
Intelligent Hearing Systems
Neurology · 183d
Cleared May 11, 1993
RS OPTIGUARD GOWN & DRAPE MATERIAL
K925715 · FYA
Baxter Healthcare Corp
General Hospital · 180d
Cleared May 11, 1993
IN-VITRO DIAGNOSTIC REAGENT SET
K930074 · JGJ
Horizon Diagnostics, Inc.
Chemistry · 124d
Cleared May 11, 1993
SYNELISA SM ABS/RNP-SM ABS
K930141 · LKP
Elias U.S.A., Inc.
Immunology · 119d
Cleared May 11, 1993
SYNELISA U1-SNRNP (68KDA)-ANTIBODIES
K930142 · LKO
Elias U.S.A., Inc.
Immunology · 119d
Cleared May 11, 1993
AYNELISA M2-ANTIBODIES
K930143 · DBM
Elias U.S.A., Inc.
Immunology · 119d
Cleared May 11, 1993
TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM)
K930148 · GKZ
Heraeus Kulzer, Inc.
Hematology · 119d
Cleared May 11, 1993
THROMBOPLATIN-M WITH CALCIUM
K930212 · GJS
Sigma Diagnostics, Inc.
Hematology · 116d
Cleared May 11, 1993
DELFIA(R) HGH KIT
K930484 · CFL
Wallac OY
Chemistry · 102d
Cleared May 11, 1993
BARD WILLIAM HARVEY TWO STAGE CANNULA
K930684 · DWF
C.R. Bard, Inc.
Cardiovascular · 90d
Cleared May 11, 1993
BACTIDROP(TM) MUCAP
K930878 · JTO
Remel Co.
Microbiology · 81d
Cleared May 11, 1993
SYNERMED CREATINE KINASE REAGENT KIT
K930932 · CGS
Synermed, Inc.
Chemistry · 77d
Cleared May 11, 1993
HEMOCARD CONTROL HB-AA, AE, FAA, FAE
K931234 · JCM
Isolab, Inc.
Chemistry · 62d
Cleared May 11, 1993
IL TEST PHOSPHORUS
K931361 · CEO
Instrumentation Laboratory CO
Chemistry · 55d
Cleared May 11, 1993
VACUTAINER BRAND LUER ADAPTER
K931367 · JKA
Bd Becton Dickinson Vacutainer...
Chemistry · 55d
Cleared May 11, 1993
IMMULITE CORTISOL
K931409 · CGR
Diagnostic Products Corp.
Chemistry · 53d
Cleared May 11, 1993
FERRIC CHLORID REAGENT, 10%
K931413 · JTO
Hardy Diagnostics
Microbiology · 89d
Cleared May 11, 1993
CHEK-STIX CONTROL STRIPS FOR URINALYSIS
K931467 · JJW
Heraeus Kulzer, Inc.
Toxicology · 48d
Cleared May 11, 1993
BILE SPOT REAGENT
K931530 · JTN
Hardy Diagnostics
Microbiology · 89d