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
130225–130248 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 15, 1989
INNOFLUOR CARBAMAZEPINE CALIBRATOR SET
K893506 · DLJ
Innotron of Oregon, Inc.
Chemistry · 102d
Cleared Aug 15, 1989
TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF
K893519 · KZB
Statlabs, Inc.
Microbiology · 99d
Cleared Aug 15, 1989
OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID
K893528 · ESD
Oticon Corp.
Ear, Nose, Throat · 99d
Cleared Aug 15, 1989
BECKMAN CHOLINESTERASE REAGENT KIT
K893583 · DIH
Beckman
Chemistry · 98d
Cleared Aug 15, 1989
STERILIZATION TRAY LINER
K893764 · FRG
Ahlstrom Dexter
General Hospital · 88d
Cleared Aug 15, 1989
MODIFIED PK300 AUTOMATIC EIA ANALYZER
K893768 · JJF
Olympus Corp.
Chemistry · 88d
Cleared Aug 15, 1989
MODEL 0183010, PEARL MEDICAL EXAM LIGHT
K893807 · KZF
Burton Medical Products Corp.
General Hospital · 85d
Cleared Aug 15, 1989
MODEL 0450000, OPAL MEDICAL EXAM LIGHT
K893808 · KZF
Burton Medical Products Corp.
General Hospital · 85d
Cleared Aug 15, 1989
FD3500 (DENTAL CHAIR)
K893889 · KLC
Oriola OY Finndent
Dental · 77d
Cleared Aug 15, 1989
FD4500 (DENTAL CHAIR)
K893890 · KLC
Oriola OY Finndent
Dental · 77d
Cleared Aug 15, 1989
FD 200 DENTAL STOOL
K893943 · KLC
Oriola OY Finndent
Dental · 76d
Cleared Aug 15, 1989
FD 300 DENTAL STOOL
K893944 · KLC
Oriola OY Finndent
Dental · 76d
Cleared Aug 15, 1989
ABSOLUTE(TM)-HCG URINE PREGNANCY TEST
K893953 · DHA
Totem Diagnostics, Inc.
Chemistry · 75d
Cleared Aug 15, 1989
GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS
K893977 · JWY
Baxter Healthcare Corp
Microbiology · 74d
Cleared Aug 15, 1989
HGB-CAL SET/MULTIPLE
K893984 · KRZ
R&D Systems, Inc.
Hematology · 71d
Cleared Aug 15, 1989
HGB-CONTROL SET/MULTIPLE
K893985 · GGM
R&D Systems, Inc.
Hematology · 71d
Cleared Aug 15, 1989
LEECO VIS-DISK STREP-A (EIA)
K894122 · GTZ
Leeco Diagnostics, Inc.
Microbiology · 64d
Cleared Aug 15, 1989
ROBOTIC SAMPLE PROCESSOR
K894126 · JQW
Tecan U.S., Ltd.
Chemistry · 64d
Cleared Aug 15, 1989
RUBBER TREE BRAND
K894214 · LYY
Jinmei International, Inc.
General Hospital · 57d
Cleared Aug 15, 1989
MERIVIEW TM TRICHOMONAS
K894246 · JWZ
Meridian Diagnostics, Inc.
Microbiology · 55d
Cleared Aug 15, 1989
KDF-2.3
K894264 · HDR
Unimar, Inc.
Obstetrics & Gynecology · 56d
Cleared Aug 15, 1989
DENLEY WELLWASH 2 AND 4
K894271 · JQW
Denley Instruments, Inc.
Chemistry · 54d
Cleared Aug 15, 1989
LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST
K894279 · CEP
Bd Becton Dickinson Vacutainer...
Chemistry · 53d
Cleared Aug 15, 1989
DIDECO-SHILEY UNIVERSAL Y
K894294 · CAC
Shiley, Inc.
Anesthesiology · 53d