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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
138553–138576 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 21, 1987
BIOPSY NEEDLE GUIDE KIT, STERILE
K871467 · FCG
Amedic USA
Gastroenterology & Urology · 129d
Cleared Aug 21, 1987
DECUB-I-CON 800 AND 900 SYSTEM
K871614 · IOQ
Wholesale Medical Supply, Inc.
Physical Medicine · 119d
Cleared Aug 21, 1987
DYNO-MAX II - COMPUTERIZED MUSCLE ANALYZER
K872199 · IKK
Dyno-Max Co.
Physical Medicine · 74d
Cleared Aug 21, 1987
GEN-PROBE (R) LUMINOMETER - LEADER (TM)
K872219 · JJQ
Gen-Probe, Inc.
Chemistry · 70d
Cleared Aug 21, 1987
ACS HI-TORQUE FLEX-T GUIDE WIRE (MODIFICATION)
K872220 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 73d
Cleared Aug 21, 1987
ISO-DATA 100 SERIES GAMMA COUNTER
K872429 · JJJ
Iso-Data, Inc.
Toxicology · 60d
Cleared Aug 21, 1987
ISO-DATA 500 SERIES GAMMA COUNTER
K872430 · JJJ
Iso-Data, Inc.
Toxicology · 60d
Cleared Aug 21, 1987
CEDIA(TM) T UPTAKE
K872447 · KHQ
Microgenics Corp.
Chemistry · 59d
Cleared Aug 21, 1987
BILE ACIDS CALIBRATOR
K872451 · JIT
Sigma Diagnostics, Inc.
Chemistry · 59d
Cleared Aug 21, 1987
ASSERACHROM PROTEIN S TEST KIT
K872479 · GGP
American Bioproducts Co.
Hematology · 59d
Cleared Aug 21, 1987
VISION(R) TOTAL BILIRUBIN
K872487 · CIG
Abbott Laboratories
Chemistry · 59d
Cleared Aug 21, 1987
EMDS TOTAL BILIRUBIN (TBIL) TESTPACKS, #67675/95
K872512 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 58d
Cleared Aug 21, 1987
EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 16604
K872513 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 58d
Cleared Aug 21, 1987
INNOTRON INNOFLUOR PHEYTOIN REAGENT SET
K872563 · LGR
Innotron of Oregon, Inc.
Chemistry · 58d
Cleared Aug 21, 1987
THE PORTABLE ORDERLY
K872900 · FWZ
Edgewater Medical Equipment Systems
General & Plastic Surgery · 28d
Cleared Aug 21, 1987
BIOTROL CHOLESTEROL ENZYMATIQUE COLOR
K872930 · CHH
Biotrol, USA, Inc.
Chemistry · 25d
Cleared Aug 21, 1987
POREX QUALITY PLASTIC SURGERY INSTRUMENTS
K872947 · KDG
Porex Medical
General & Plastic Surgery · 24d
Cleared Aug 21, 1987
DELFIA(TM) FERRITIN KIT
K872955 · JMG
Lkb Instruments, Inc.
Microbiology · 23d
Cleared Aug 21, 1987
MICRINS NEEDLE HOLDER
K872989 · HXK
Micrins Surgical, Inc.
Orthopedic · 21d
Cleared Aug 21, 1987
RPMI-1640 MEDIUM (HAT MODIFIED) NO. 200-2080
K873084 · KIT
J R Scientific
Pathology · 15d
Cleared Aug 21, 1987
WAYMOUTH 752/1 MEDIUM (MODIFIED) NO. 200-2085
K873085 · KIT
J R Scientific
Pathology · 15d
Cleared Aug 21, 1987
INSTANT HEMATOXYLIN
K873107 · HYK
Shandon, Inc.
Pathology · 14d
Cleared Aug 19, 1987
SM PART SERVO SEC. DUPLEX DOP 7-5/5 9814-219-50007
K854654 · IYO
Philips Medical Systems, Inc.
Radiology · 638d
Cleared Aug 19, 1987
TOTAL BILIRUBIN REAGENT - DMSO METHOD
K870364 · CIG
Trace Scientific , Ltd.
Chemistry · 203d