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
101977–102000 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 11, 1995
CRUCIATE RETAINING (AUGMENTABLE) AND CONSTRAINED CONDYLAR KNEE (CCK)
K946150 · JWH
Zimmer, Inc.
Orthopedic · 207d
Cleared Jul 11, 1995
COLUMNMATE II GHB AFFINITY REGENERABLE COLUMN
K946274 · LCP
Helena Laboratories
Chemistry · 200d
Cleared Jul 11, 1995
ABSORBABLE ACETABULAR SCREW
K946347 · HWC
Zimmer, Inc.
Orthopedic · 193d
Cleared Jul 11, 1995
BIO-VENT IMPLANT
K950575 · DZE
Core-Vent Corp.
Dental · 165d
Cleared Jul 11, 1995
BIO-VENT X IMPLANT
K950576 · DZE
Core-Vent Corp.
Dental · 165d
Cleared Jul 11, 1995
SWEDE-VENT IMPLANT
K950577 · DZE
Core-Vent Corp.
Dental · 165d
Cleared Jul 11, 1995
SCREW-VENT IMPLANT
K950578 · DZE
Core-Vent Corp.
Dental · 165d
Cleared Jul 11, 1995
MICRO-VENT IMPLANT
K950579 · DZE
Core-Vent Corp.
Dental · 165d
Cleared Jul 11, 1995
OGDEN ANCHOR
K950875 · HWC
American Medical Electronics, Inc.
Orthopedic · 133d
Cleared Jul 11, 1995
HOLLISTER HYDROCOLLOID WOUND DRESSINGS
K950933 · FRO
Hollister, Inc.
General & Plastic Surgery · 132d
Cleared Jul 11, 1995
INTRODUCER
K951090 · GCJ
Ranfac, Corp.
General & Plastic Surgery · 124d
Cleared Jul 11, 1995
CEDIA VITAMIN B12 (NO BOIL) ASSAY
K951134 · CDD
Microgenics Corp.
Chemistry · 120d
Cleared Jul 11, 1995
PHENO-CEN GERMICIDAL DETERGENT
K951162 · LRJ
Central Solutions, Inc.
General Hospital · 119d
Cleared Jul 11, 1995
BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT
K951538 · CEP
Syntron Bioresearch, Inc.
Chemistry · 99d
Cleared Jul 11, 1995
GOLD CD ULTRA MINI CANAL - MODULE
K951642 · ESD
Electone, Inc.
Ear, Nose, Throat · 92d
Cleared Jul 11, 1995
DURACON RECESSED PATELLA
K951655 · JWH
Howmedica Corp.
Orthopedic · 92d
Cleared Jul 11, 1995
CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER
K951714 · GEX
Cabot Medical Corp.
General & Plastic Surgery · 88d
Cleared Jul 11, 1995
APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE
K951721 · LYK
Applied Medical Resources
Cardiovascular · 88d
Cleared Jul 11, 1995
CARIES DETECTOR
K951813 · LFC
Kuraray Co.
Dental · 84d
Cleared Jul 11, 1995
STERICARE WOUND CARE GEL
K951861 · MGQ
Acacia Laboratories, Inc.
General & Plastic Surgery · 81d
Cleared Jul 11, 1995
SCISSORS, UNIVERSAL, LAPAROSCOPIC W/MONOPOLAR CAUTERY REUSABLE
K951905 · GEI
H.S. Intl. Co., Inc.
General & Plastic Surgery · 78d
Cleared Jul 11, 1995
CEMENTRALIZER DISTAL STEM CENTRALIZER
K951930 · LZN
Depuy, Inc.
Orthopedic · 97d
Cleared Jul 11, 1995
CLEAN-CUFF
K952038 · KCY
Instrumed, Inc.
General & Plastic Surgery · 71d
Cleared Jul 11, 1995
ABELSON CRICOTHYROTOMY CANNULA
K952401 · BWC
Gilbert Surgical Instruments, Inc.
Anesthesiology · 50d