FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
92137–92160 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 1997
ANEUVYSION
K972200 · OYU
Vysis
Pathology · 132d
Cleared Oct 20, 1997
N-ASSAY TIA ANTITHROMBIN III TEST KIT
K972257 · DDQ
Crestat Diagnostics, Inc.
Hematology · 125d
Cleared Oct 20, 1997
CS-400 COAGULATION ANALYZER SYSTEM (A1208)
K972260 · JPA
Sigma Diagnostics, Inc.
Hematology · 125d
Cleared Oct 20, 1997
HEMAPROMPT
K972763 · KHE
Aerscher Diagnostics
Hematology · 88d
Cleared Oct 20, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS3030-P
K972779 · MRZ
Alexander Mfg. Co.
General Hospital · 87d
Cleared Oct 20, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625
K972780 · MRZ
Alexander Mfg. Co.
General Hospital · 87d
Cleared Oct 20, 1997
N ANTISERUM TO HUMAN ALBUMIN
K972929 · DCF
Behring Diagnostics, Inc.
Immunology · 73d
Cleared Oct 20, 1997
QUANTA LITE B2 GPI IGA
K973006 · MSV
Inova Diagnostics, Inc.
Immunology · 68d
Cleared Oct 20, 1997
QUANTA LITE B2GPI IGM
K973014 · MSV
Inova Diagnostics, Inc.
Immunology · 68d
Cleared Oct 20, 1997
ISLAND BIOSURGICAL INC. BNS KIT #1 & #2
K973022 · OTN
Island Biosurgical, Inc.
Gastroenterology & Urology · 67d
Cleared Oct 20, 1997
DBEST REAGENT STRIP FOR URINALYSIS
K973142 · JIL
Ameritek, Inc.
Chemistry · 60d
Cleared Oct 20, 1997
FIRST SIGN
K973208 · LCX
Texas Immunology, Inc.
Chemistry · 54d
Cleared Oct 20, 1997
I-STAT SYSTEM
K973292 · CGL
I-Stat Corp.
Chemistry · 48d
Cleared Oct 20, 1997
REXAM FRACTURE RESISTANT POUCH
K973440 · KCT
Rexam Medical Packaging, Inc.
General Hospital · 40d
Cleared Oct 20, 1997
ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS
K973535 · KLT
Schiapparelli Biosystems, Inc.
Chemistry · 32d
Cleared Oct 20, 1997
TROPONIN (TROP) METHOD
K973650 · MMI
Dade Chemistry Systems, Inc.
Chemistry · 25d
Cleared Oct 20, 1997
CARDIAC TROPONIN-I (TROP) CALIBRATOR
K973668 · JIT
Dade Intl., Inc.
Chemistry · 25d
Cleared Oct 17, 1997
ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS
K970864 · FOZ
Arrow Intl., Inc.
General Hospital · 221d
Cleared Oct 17, 1997
SOFT TIP EPIDURAL CATHETER KIT
K971233 · CAZ
B.Braun Medical, Inc.
Anesthesiology · 198d
Cleared Oct 17, 1997
MAGI ACUPUNCTURE NEEDLES
K972658 · MQX
Dong Bang, U.S.A.
General Hospital · 94d
Cleared Oct 17, 1997
DONG BANG ACUPUNCTURE NEEDLES
K972659 · MQX
Dong Bang, U.S.A.
General Hospital · 94d
Cleared Oct 17, 1997
SIEMENS MULTIVIEW WORKSTATION INFINITY TELEMETRY SYSTEM
K972714 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 88d
Cleared Oct 17, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL9366
K972786 · DQA
Alexander Mfg. Co.
Anesthesiology · 84d
Cleared Oct 17, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M850-P
K972787 · DRT
Alexander Mfg. Co.
Cardiovascular · 84d