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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
112033–112056 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 1993
SPECTACLE FRAME
K932802 · HQZ
Insight Optical Mfg. Co. of Florida,...
Ophthalmic · 92d
Cleared Sep 09, 1993
HRV 4000EM
K932929 · DSH
All-Tronics Medical Systems
Radiology · 86d
Cleared Sep 09, 1993
NEW STAR, TAE HAN OPTICAL
K932999 · HQZ
J.B. Eyewear, Inc.
Ophthalmic · 83d
Cleared Sep 09, 1993
LAPAROSCOPIC SURGICAL RETRACTOR
K933032 · GCJ
Advanced Surgical, Inc.
General & Plastic Surgery · 79d
Cleared Sep 09, 1993
SCIMED VIPER
K933183 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 71d
Cleared Sep 09, 1993
KARL STORZ ENDOSCOPY-AMERICA, INC.
K933216 · FFS
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 135d
Cleared Sep 09, 1993
745 GLYCOMAT
K933287 · LCP
Drew Scientific , Ltd.
Hematology · 65d
Cleared Sep 09, 1993
SPECTACLE FRAMES
K933313 · HQZ
Serrao Optical Intl., Inc.
Ophthalmic · 64d
Cleared Sep 09, 1993
FRAME, SPECTACLE
K933436 · HQZ
Aoyama Optical Co., Ltd.
Ophthalmic · 58d
Cleared Sep 09, 1993
PERSONAL BEST LOW RANGE
K933889 · BZH
Healthscan Products, Inc.
Anesthesiology · 30d
Cleared Sep 09, 1993
HP M1465A STANDARD AIRWAY ADAPTER
K933980 · CCK
Hewlett-Packard Co.
Anesthesiology · 24d
Cleared Sep 08, 1993
GLUCOFILM TEST STRIPS
K926360 · CGA
Heraeus Kulzer, Inc.
Chemistry · 261d
Cleared Sep 08, 1993
ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM
K930979 · CGA
Boehringer Mannheim Corp.
Chemistry · 195d
Cleared Sep 08, 1993
ENCORE ENA COMBINED EIA
K931543 · LLL
Clark Laboratories, Inc.
Immunology · 163d
Cleared Sep 08, 1993
CHEMILUMINESCENCE FREE T3 IMMUNOASSAY
K931600 · CDP
Nichols Institute
Chemistry · 160d
Cleared Sep 08, 1993
OLYMPUS REPLY INORGANIC PHOSPHOROUS REAGENT
K931835 · CEO
Olympus Corp.
Chemistry · 148d
Cleared Sep 08, 1993
SYNERMED GGT REAGENT KIT
K931958 · JQB
Synermed, Inc.
Chemistry · 141d
Cleared Sep 08, 1993
AMP ALKALINE PHOSPHATASE REAGENT KIT
K931986 · CJE
Synermed, Inc.
Chemistry · 139d
Cleared Sep 08, 1993
UREA NITROGEN TEST ITEM NUMBER 65408
K932161 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 127d
Cleared Sep 08, 1993
EYE SPOT IM TEST
K932688 · KTN
J.S. Medical Assoc.
Immunology · 97d
Cleared Sep 08, 1993
UIBC FOR DISCREET RANDOM ACCESS ANALYZER
K932871 · CFM
Catachem, Inc.
Chemistry · 86d
Cleared Sep 08, 1993
OPUS ESTRADIOL
K933066 · CHP
Pb Diagnostic Systems, Inc.
Chemistry · 78d
Cleared Sep 08, 1993
RADIAS FERRITIN ENZYME IMMUNOASSAY
K933314 · DEW
Bio-Rad
Immunology · 63d
Cleared Sep 08, 1993
OPUS TOTAL CK
K933675 · CGS
Pb Diagnostic Systems, Inc.
Chemistry · 42d