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
134617–134640 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 08, 1988
ACUSON I7505 TRANSDUCER, ULTRASOUND TRANSDUCER
K882737 · IYN
Acuson Corp.
Radiology · 69d
Cleared Sep 08, 1988
TRACHEAL TUBE LASER SHIELD KIT
K883096 · BTR
Americal Corp.
Anesthesiology · 48d
Cleared Sep 08, 1988
CATAPULT BUCKY (KATAPULT BLENDA)
K883160 · KPR
Bay X-Ray, Inc.
Radiology · 44d
Cleared Sep 07, 1988
MICROLYTE 7
K880973 · JFP
The Rupp & Bowman Co.
Chemistry · 183d
Cleared Sep 07, 1988
VAC (OSCILLATING VITRECTOR)
K881520 · HQE
B&B Medical Assoc., Inc.
Ophthalmic · 149d
Cleared Sep 07, 1988
HEMATRAK(R) MODEL 590
K882579 · GKZ
Priority Service Systems
Hematology · 76d
Cleared Sep 07, 1988
SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER
K882612 · GKZ
Baker Instructions Corp.
Hematology · 75d
Cleared Sep 07, 1988
ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST
K882998 · DCK
Amtec Diagnostics International, Inc.
Immunology · 51d
Cleared Sep 07, 1988
GRAM NEGATIVE & GRAM POSITIVE MIC/COMBO PANELS
K883076 · JWY
Baxter Healthcare Corp
Microbiology · 56d
Cleared Sep 07, 1988
HISTONE REACTIVE ANA
K883232 · LLL
Val Tech Diagnostics, Inc.
Immunology · 37d
Cleared Sep 07, 1988
DHBTI-ALLERGEN IGE FASTSCREEN IV (G1,G5,G12,G13)
K883273 · DHB
3M Company
Immunology · 35d
Cleared Sep 07, 1988
QLIA IMMUNOCHEMISTRY SYSTEM
K883349 · JZT
Bd Becton Dickinson Vacutainer...
Immunology · 29d
Cleared Sep 07, 1988
UBI MAGIWEL RF-IGM QUANTITATIVE
K883355 · DHR
United Biotech, Inc.
Immunology · 29d
Cleared Sep 07, 1988
RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST
K883385 · JXA
Los Alamos Diagnostics
Microbiology · 29d
Cleared Sep 07, 1988
GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS
K883394 · JWY
Baxter Healthcare Corp
Microbiology · 27d
Cleared Sep 07, 1988
TECHNICON DPA-1 APOLIPOPROTEIN B
K883491 · MSJ
Technicon Instruments Corp.
Immunology · 22d
Cleared Sep 07, 1988
TECHNICON DPA-1 IMMUNOGLOBULIN G
K883494 · DAH
Technicon Instruments Corp.
Immunology · 22d
Cleared Sep 07, 1988
QM300 RHEUMATOID FACTOR ANTIGEN PACK
K883536 · DHR
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 20d
Cleared Sep 07, 1988
QM300 CALIBRATOR E PACK
K883538 · DHR
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 20d
Cleared Sep 07, 1988
EX-CELL 300TM, CATALOG NO. 200-3600
K883623 · KIT
J R Scientific
Pathology · 16d
Cleared Sep 07, 1988
EX-CELL 300TM, CATALOG NO. 200-3601
K883624 · KIT
J R Scientific
Pathology · 16d
Cleared Sep 07, 1988
EX-CELL 301, CATALOG NO. 200-3651
K883625 · KIT
J R Scientific
Pathology · 16d
Cleared Sep 07, 1988
EX-CELL 301, CATALOG NO. 210-3577
K883626 · KIT
J R Scientific
Pathology · 16d
Cleared Sep 07, 1988
MIN ESSENT MED EAGLE, JOKLIK MOD, CAT. #200-2150
K883627 · KIT
J R Scientific
Pathology · 16d