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
86137–86160 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 01, 1999
ATLAS-ELITE,MODEL E-80,CORIUM 200,CORIUM 400, MODEL E-90, ELITE, MODEL...
K990174 · GEX
Fisma, Inc.
General & Plastic Surgery · 72d
Cleared Apr 01, 1999
MDILOG, MODEL MDC-512
K990185 · CAF
Medtrak Technologies, Inc.
Anesthesiology · 71d
Cleared Apr 01, 1999
INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM, MODEL SVS-1
K990188 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 71d
Cleared Apr 01, 1999
CRX WORLD SHUNT
K990256 · JXG
Phoenix Biomedical Corp.
Neurology · 64d
Cleared Apr 01, 1999
OMNI-FIX, NAIL SYSTEM
K990307 · KTW
Turnkey Intergration USA, Inc.
Orthopedic · 59d
Cleared Apr 01, 1999
PERRY HUMERAL NAIL
K990322 · HSB
Pioneer Surgical Technology
Orthopedic · 58d
Cleared Apr 01, 1999
COULTER AC T DIFF 2 ANALYZER
K990352 · GKZ
Coulter Corp.
Hematology · 55d
Cleared Apr 01, 1999
MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTURE
K990951 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 10d
Cleared Apr 01, 1999
NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES
K990952 · GAT
United States Surgical, A Division of...
General & Plastic Surgery · 10d
Cleared Mar 31, 1999
HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAM
K990086 · KGN
Integra Lifesciences Corp.
General & Plastic Surgery · 79d
Cleared Mar 31, 1999
MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM
K990220 · FCG
Medi-Globe Corp.
Gastroenterology & Urology · 68d
Cleared Mar 31, 1999
DGTX FLEX REAGENT CARTRIDGE, MODEL DF36
K990251 · LFM
Dade Behring, Inc.
Toxicology · 63d
Cleared Mar 31, 1999
COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR...
K990264 · HQD
Metro Optics of Austin, Inc.
Ophthalmic · 63d
Cleared Mar 31, 1999
VEGA RETIC AUTOMATED HEMATOLOGY ANALYZER
K990311 · GKZ
Abx Diagnostics
Hematology · 58d
Cleared Mar 31, 1999
ENDOSHEATH
K990354 · EOB
Vision-Sciences, Inc.
Ear, Nose, Throat · 54d
Cleared Mar 31, 1999
ABBOTT LIQUID IMMUNOLOGY CONTROL MODELS 2E01-01/2E02-01/2E03-01
K990424 · JJY
Bio-Rad
Chemistry · 48d
Cleared Mar 31, 1999
ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEM
K990436 · HSB
Biodynamic Technologies, Inc.
Orthopedic · 48d
Cleared Mar 31, 1999
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
K990516 · DNN
Emd Chemicals, Inc.
Toxicology · 41d
Cleared Mar 31, 1999
BOJRAB MICRO-TORP, MODEL 7014-5845
K990601 · ETA
Gyrus Ent LLC
Ear, Nose, Throat · 35d
Cleared Mar 31, 1999
PRIMA SYSTEM - OLD, BARTELS ELISA - NEW
K990664 · LLH
Intracel Corp.
Microbiology · 30d
Cleared Mar 31, 1999
TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010
K990923 · ETB
Heinz Kurz
Ear, Nose, Throat · 12d
Cleared Mar 30, 1999
ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
K982660 · CAC
Transfusion Technologies Corp.
Anesthesiology · 243d
Cleared Mar 30, 1999
SAPHLIFT
K990062 · MDM
Genzyme Surgical Product (Genzyme...
General & Plastic Surgery · 81d
Cleared Mar 30, 1999
LPULSA SYL-9000 OPHTHALMIC YAG LASER
K990075 · HQF
Light-Med(Usa), Inc.
Ophthalmic · 78d