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
89689–89712 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 1998
ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST
K980736 · JHI
Acon Laboratories Co.
Chemistry · 50d
Cleared Apr 16, 1998
AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 2
K980982 · GGN
Avocet Medical, Inc.
Hematology · 30d
Cleared Apr 16, 1998
COAMATIC FACTOR VIII
K981038 · GGP
Instrumentation Laboratory CO
Hematology · 28d
Cleared Apr 16, 1998
STRATUS CS CKMB CALPAK
K981097 · JIT
Dade Behring, Inc.
Chemistry · 21d
Cleared Apr 16, 1998
STRATUS CS TROP CALPAK
K981100 · JIT
Dade Behring, Inc.
Chemistry · 21d
Cleared Apr 16, 1998
UREA NITROGEN (BUN) LIQUID REAGENT
K981106 · CDQ
Teco Diagnostics
Chemistry · 21d
Cleared Apr 16, 1998
AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST
K981165 · JHI
Germaine Laboratories, Inc.
Chemistry · 16d
Cleared Apr 15, 1998
MACRALP(A) ENZYME IMMUNOASSAY KIT
K971157 · JHO
Strategic Diagnostics, Inc.
Chemistry · 383d
Cleared Apr 15, 1998
BARD BTA TRAK TEST
K971402 · MMW
Bard Diagnostic Sciences,Inc.
Immunology · 365d
Cleared Apr 15, 1998
IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9100
K973562 · IYN
Imex Medical Systems, Inc.
Radiology · 208d
Cleared Apr 15, 1998
KSEA N2O ENDOFLATOR
K980134 · HIF
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 90d
Cleared Apr 15, 1998
UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD
K980525 · KWX
Marukin Shoyu Co., Ltd.
Chemistry · 63d
Cleared Apr 15, 1998
ND: YAG ACCESSORY FOR PHOTODERM SYSTEM
K980537 · GEX
Esc Medical Systems , Ltd.
General & Plastic Surgery · 63d
Cleared Apr 15, 1998
NTECH ARTHROSCOPE
K980599 · GCJ
N-Tech Endoscopy, Inc.
General & Plastic Surgery · 57d
Cleared Apr 15, 1998
NONWOVEN PAD
K980720 · KMF
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 50d
Cleared Apr 15, 1998
PLANCON MICROLAMELLAR KERATOME EVOLUTION
K980924 · HNO
Plancon Instruments
Ophthalmic · 35d
Cleared Apr 15, 1998
NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER
K980991 · CHL
Nova Biomedical Corp.
Chemistry · 29d
Cleared Apr 15, 1998
SOFT TISSUE PATCH PLUS, DUALMESH PLUS, MYCROMESH PLUS, DUALMESH PLUS WITH HOLES
K981051 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 28d
Cleared Apr 15, 1998
STRATUS CS MYO CALPAK
K981101 · JIT
Dade Behring, Inc.
Chemistry · 20d
Cleared Apr 14, 1998
MUSCLE RESPONSE MONITOR
K971400 · HCC
Enriching Your Life
Neurology · 364d
Cleared Apr 14, 1998
PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE
K972201 · DXZ
Sulzer Carbomedics, Inc.
Cardiovascular · 307d
Cleared Apr 14, 1998
RUSCH SINGLE USE CRYSTAL TRACHEOSTOMY TUBE SET
K972546 · JOH
Rusch Intl.
Anesthesiology · 280d
Cleared Apr 14, 1998
BIOFIX BIODEGRADABLE THREADED SUTURE ANCHOR
K972783 · MAI
Bionx Implants, Inc.
Orthopedic · 263d
Cleared Apr 14, 1998
CH-611B AND CH-611C DIGITAL WRIST SPHYGMOMANOMETERS BLOOD PRESSURE METER
K973613 · DXN
Foley & Lardner
Cardiovascular · 204d