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
96817–96840 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 1996
PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20
K960761 · HCC
The Prometheus Group
Neurology · 163d
Cleared Aug 07, 1996
KINEMATIC II REPLACEMENT TIBIAL INSERTS
K960976 · JWH
Howmedica Corp.
Orthopedic · 149d
Cleared Aug 07, 1996
SYNTHES ANATOMICAL LOCKING PLATE SYSTEM
K961413 · HWC
Synthes (Usa)
Orthopedic · 117d
Cleared Aug 07, 1996
DENTAL DAM SILICONE
K961472 · EIE
Worldwide Dental, Inc.
Dental · 112d
Cleared Aug 07, 1996
COSGROVE DEPTH ELECTRODE KIT(CDEK)
K961858 · HAW
Radionics, Inc.
Neurology · 85d
Cleared Aug 07, 1996
PISTON SYRINGE
K961877 · FMI
Univec, Inc.
General Hospital · 89d
Cleared Aug 07, 1996
MULTI-TEST II
K961918 · SCL
Lincoln Diagnostics, Inc.
General Hospital · 82d
Cleared Aug 07, 1996
CPS, CEMENTED CUP SYSTEM
K962086 · JDI
Artos Medical Products GmbH
Orthopedic · 70d
Cleared Aug 07, 1996
V.R.S. DENTURE RESIN MATERIAL
K962333 · EBI
Vident
Dental · 51d
Cleared Aug 07, 1996
TOPOGRAPHIC IMAGING MARKER
K962606 · JAA
I.Z.I. Medical Products Corp.
Radiology · 36d
Cleared Aug 06, 1996
IMPACT AIR 45 4-HOLE
K952927 · EFB
Palisades Pharmaceutics, Inc.
Dental · 407d
Cleared Aug 06, 1996
BEAR CUB INFANT PRESSURE VENTILATOR
K955865 · CBK
Allied Healthcare Products, Inc.
Anesthesiology · 222d
Cleared Aug 06, 1996
MANDIBULAR BONE DISTRACTOR II
K960297 · MQN
Howmedica Corp.
Dental · 197d
Cleared Aug 06, 1996
CONTROL SYRINGE
K960430 · DXT
Scientific Device Manufacturer, LLC
Cardiovascular · 188d
Cleared Aug 06, 1996
HEARTRAK XL
K960499 · DXH
Universal Medical, Inc.
Cardiovascular · 186d
Cleared Aug 06, 1996
MULTI LEAF COLLIMATOR
K961214 · IYE
Mitsubishi Intl. Corp.
Radiology · 131d
Cleared Aug 06, 1996
ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493
K961825 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 88d
Cleared Aug 06, 1996
STORZ DP5200 IRRIGATION ADDMINISTRATION SET PACK
K961831 · HQC
Storz Instrument Co.
Ophthalmic · 85d
Cleared Aug 06, 1996
STORZ DP5100 ANTERIOR COLLECTION CASSETTE PACK
K961874 · HQC
Storz Instrument Co.
Ophthalmic · 83d
Cleared Aug 06, 1996
BONE & MARROW COLLECTION SYSTEM
K961901 · GEY
Biomedical Ent., Inc.
General & Plastic Surgery · 82d
Cleared Aug 06, 1996
MEDICINELODGE, INC. SET SCREW
K961905 · HWC
Medicinelodge, Inc.
Orthopedic · 82d
Cleared Aug 06, 1996
SPIRIT S1/S2
K962071 · EIA
Pelton & Crane Co.
Dental · 70d
Cleared Aug 06, 1996
SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH
K962456 · ELM
Ivoclar North America, Inc.
Dental · 42d
Cleared Aug 06, 1996
PULPDENT SODIUM HYPOCHLORITE SOLUTION
K962743 · KJJ
Pulpdent Corp.
Dental · 22d