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
86425–86448 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 1999
QUINTON MEDTRACK CR PLUS TREADMILL
K990866 · ISD
Quinton, Inc.
Physical Medicine · 44d
Cleared Apr 29, 1999
FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER
K990906 · KMF
Ferris Mfg. Corp.
General & Plastic Surgery · 42d
Cleared Apr 29, 1999
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K991092 · KWQ
Electro-Biology, Inc.
Orthopedic · 28d
Cleared Apr 29, 1999
SOFT TISSUE SUTURE WASHER
K991135 · HTN
Depuy, Inc.
Orthopedic · 24d
Cleared Apr 29, 1999
HI-TORQUE BALANCE TREK GUIDE WIRE
K991152 · DQX
Guidant Corp.
Cardiovascular · 23d
Cleared Apr 29, 1999
HYDRO-CAST ACRYLIC VARNISH, MODEL 78125
K991161 · EIA
Kay See Dental Mfg. Co.
Dental · 22d
Cleared Apr 28, 1999
WATER TREATMENT SYSTEM FOR HEMODIALYSIS
K983512 · FIP
Water Vault, Inc.
Gastroenterology & Urology · 203d
Cleared Apr 28, 1999
TRINITY II SINGLE CHAMBER DVT PUMP
K983680 · JOW
Delphi Consulting Group
Cardiovascular · 190d
Cleared Apr 28, 1999
STAINLESS STEEL NONABSORBABLE SURGICAL SUTURE, USP
K984151 · GAQ
Mill Pond, Inc.
General & Plastic Surgery · 160d
Cleared Apr 28, 1999
BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-471
K984223 · DXN
Citizen Watch Co., Ltd.
Cardiovascular · 154d
Cleared Apr 28, 1999
KERAVISION VACUUM RING SYSTEM
K984540 · HNO
Keravision, Inc.
Ophthalmic · 128d
Cleared Apr 28, 1999
MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012,...
K990333 · GWG
Medtronic PS Medical
Neurology · 84d
Cleared Apr 28, 1999
AUTOSTAT II ANTI-SM/RNP ELISA
K990624 · LKO
Cogent Diagnotics , Ltd.
Immunology · 62d
Cleared Apr 28, 1999
AUTOSTAT II ANTI-SM ELISA
K990625 · LKP
Cogent Diagnotics , Ltd.
Immunology · 62d
Cleared Apr 28, 1999
AUTOSTAT II ANTI-SS-B/LA ELISA
K990626 · LLL
Cogent Diagnotics , Ltd.
Immunology · 62d
Cleared Apr 28, 1999
AUTOSTAT II ANTI-SS-A/RO ELISA
K990627 · LLL
Cogent Diagnotics , Ltd.
Immunology · 62d
Cleared Apr 28, 1999
DAUM NEUROGATE TROCAR
K990782 · KNW
Daum GmbH
Gastroenterology & Urology · 50d
Cleared Apr 28, 1999
AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA
K990796 · MOB
Cogent Diagnotics , Ltd.
Immunology · 49d
Cleared Apr 28, 1999
AUTOSTAT II ANTI-SCL-70 ELISA
K990797 · LLL
Cogent Diagnotics , Ltd.
Immunology · 49d
Cleared Apr 28, 1999
AUTOSTAT II ANTI-JO-1 ELISA
K990798 · LLL
Cogent Diagnotics , Ltd.
Immunology · 49d
Cleared Apr 28, 1999
QUICKCARD HCG COMBO TEST, MODEL #9014
K991095 · JHI
Phamatech
Chemistry · 27d
Cleared Apr 28, 1999
GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
K991411 · BZQ
Gereonics, Inc.
Anesthesiology · 33d
Cleared Apr 27, 1999
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K983711 · JWY
Dade Microscan, Inc.
Microbiology · 188d
Cleared Apr 27, 1999
RENU MULTIPLUS MULTI-PURPOSE SOLUTION
K990422 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 75d