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
89473–89496 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 25, 1998
CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM
K961320 · HWC
Buckman Co., Inc.
Orthopedic · 811d
Cleared Jun 25, 1998
BECTON DICKINSON SYRINGES
K980580 · FMF
Bd Becton Dickinson Vacutainer...
General Hospital · 128d
Cleared Jun 25, 1998
VED VALU- VACUUM ERECTION DEVICE
K980948 · LKY
Mission Pharmacal Comp
Gastroenterology & Urology · 104d
Cleared Jun 25, 1998
MICROCAP
K981114 · CCK
Oridion Medical , Ltd.
Anesthesiology · 90d
Cleared Jun 25, 1998
RADIO-PLAST
K981115 · LHN
Smith & Nephew, Inc.
Radiology · 90d
Cleared Jun 25, 1998
CERALAS G FREQUENCY DOUBLED ND: YAG LASER SYSTEMS, CERALAS G3
K981126 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 90d
Cleared Jun 25, 1998
MINRAD DRTS LIGHT SABER SYRINGE
K981140 · FMF
Minrad, Inc.
General Hospital · 87d
Cleared Jun 25, 1998
CLEARPLAN EASY OVULATION TEST
K981271 · CEP
Unipath , Ltd.
Chemistry · 79d
Cleared Jun 25, 1998
SYNTHES (USA) RATCHETING DISTRACTOR
K981275 · MQN
Synthes (Usa)
Dental · 78d
Cleared Jun 25, 1998
SMC 28MM CERAMIC FEMORAL HEADS
K981302 · LZO
Signal Medical Corp.
Orthopedic · 77d
Cleared Jun 25, 1998
ORTHODONTIC BRACES
K981433 · DYW
Midwest Orthodontic Mfg.
Dental · 66d
Cleared Jun 25, 1998
BIOSIGN HCG I - ONE STEP PREGNANCY TEST
K981443 · JHI
Princeton BioMeditech Corp.
Chemistry · 64d
Cleared Jun 25, 1998
GC FUJI ORTHO LC
K981461 · DYH
GC America, Inc.
Dental · 63d
Cleared Jun 25, 1998
CHOL
K981476 · CHH
Abbott Laboratories
Chemistry · 62d
Cleared Jun 25, 1998
RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE...
K981506 · LKY
Repro-Med Systems, Inc.
Gastroenterology & Urology · 59d
Cleared Jun 25, 1998
CARESIDE URIC ACID
K981604 · KNK
Careside, Inc.
Chemistry · 58d
Cleared Jun 25, 1998
CARESIDE ANALYZER
K981610 · CEO
Careside, Inc.
Chemistry · 56d
Cleared Jun 25, 1998
ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002
K981838 · JHI
Unotech Diagnostics, Inc.
Chemistry · 30d
Cleared Jun 25, 1998
SPENCO SILICONE GEL SHEET
K981902 · MDA
Spenco Medical Corp.
General & Plastic Surgery · 24d
Cleared Jun 25, 1998
POLYSORB SUTURE
K981935 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 23d
Cleared Jun 25, 1998
ONE WEEK BACKSTOP DENTAL ANTI-RETRACTION CHECK VALVE
K982009 · EIA
Scitech Solutions, Inc.
Dental · 84d
Cleared Jun 25, 1998
WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD
K982097 · FMI
Worldwide Medical Technologies, LLC
General Hospital · 10d
Cleared Jun 24, 1998
SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM
K974417 · MNS
ResMed Corp
Anesthesiology · 212d
Cleared Jun 24, 1998
SEMKIN INSULATED BIPOLAR FORCEP
K974593 · HTD
Titan Mfg., Inc.
General & Plastic Surgery · 197d