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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
127825–127848 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 1989
FRESENIUS BIOCARB HEMODIALYSIS GRADE SODIUM BICARB
K896111 · KPO
Fresenius USA, Inc.
Gastroenterology & Urology · 65d
Cleared Dec 27, 1989
ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY
K896145 · CHP
Serono-Baker Diagnostics, Inc.
Chemistry · 65d
Cleared Dec 27, 1989
SUNTANNING BED, INC. T12 UVA TANNING LAMPS
K896191 · FTC
Sunbronze
General & Plastic Surgery · 62d
Cleared Dec 27, 1989
WILSON-COOK ESOPHAGEAL PROSTHESIS
K896390 · JCQ
Wilson-Cook Medical, Inc.
General & Plastic Surgery · 51d
Cleared Dec 27, 1989
ARTHROSCOPIC TUBING SHEATH
K896584 · HRX
Origin Medsystems, Inc.
Orthopedic · 36d
Cleared Dec 27, 1989
MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP
K896589 · LRZ
Optik
General & Plastic Surgery · 36d
Cleared Dec 27, 1989
BECTON DICKINSON RATE INFUSER II SYSTEM
K896593 · FRN
Bd Becton Dickinson Vacutainer...
General Hospital · 36d
Cleared Dec 27, 1989
MODIFIED PROLACTIN ENZYME IMMUNOASSAY TEST KIT
K896641 · CFT
Medix Biotech, Inc.
Chemistry · 33d
Cleared Dec 27, 1989
STREAMLINE VASCULAR ACCESS DEVICE
K896774 · FOZ
Menlo Care, Inc.
General Hospital · 26d
Cleared Dec 27, 1989
SURGICAL SKIN MARKER
K896792 · FZZ
Westmark, Sterile Packing Systems,...
General & Plastic Surgery · 26d
Cleared Dec 27, 1989
LAP SPONGE
K896801 · EFQ
Westmark, Sterile Packing Systems,...
General & Plastic Surgery · 26d
Cleared Dec 27, 1989
MAGNET PAD
K896802 · LXG
Westmark, Sterile Packing Systems,...
Chemistry · 26d
Cleared Dec 27, 1989
CLOSED WOUND RESERVOIR
K896803 · GCY
Westmark, Sterile Packing Systems,...
General & Plastic Surgery · 26d
Cleared Dec 27, 1989
ALISUN SUNTANNING BED
K896831 · FTC
Alisun America, Ltd.
General & Plastic Surgery · 22d
Cleared Dec 26, 1989
MICROTEK PISTON & WIRE PROSTHESES
K895814 · ETB
Microbio-Medics, Inc.
Ear, Nose, Throat · 88d
Cleared Dec 26, 1989
MICROTEK TOTAL OSSICULAR PROTHESIS
K895815 · ETA
Microbio-Medics, Inc.
Ear, Nose, Throat · 88d
Cleared Dec 26, 1989
RAMVAC DENTAL VACUUM SYSTEM
K895876 · EIA
Ramvac Corp.
Dental · 82d
Cleared Dec 26, 1989
RAMCLEAN DENTAL VACUUM LINE CLEANER
K895877 · EIA
Ramvac Corp.
Dental · 82d
Cleared Dec 26, 1989
BAUSCH & LOMB FREQUENT REPLACEMENT CASE SYSTEM
K896685 · LRX
Bausch & Lomb, Inc.
Ophthalmic · 28d
Cleared Dec 26, 1989
PLASTIC SUNGLASSES
K896716 · HQY
Bright Horizon Ent.
Ophthalmic · 27d
Cleared Dec 26, 1989
NON-PRESCRIPTION SUNGLASSES
K896768 · HQY
Shairon Intl. Trade Co.
Ophthalmic · 25d
Cleared Dec 22, 1989
VOSS VEIN CLAMP
K885161 · DXC
Voss Medical Products
Cardiovascular · 374d
Cleared Dec 22, 1989
TISSUE OXYGEN MONITOR SYSTEM, MODEL II
K890624 · CCE
Baxter Healthcare Corp
Anesthesiology · 318d
Cleared Dec 22, 1989
SAFE-1
K893704 · DTZ
Polystan C/O Vitalcor, Inc.
Cardiovascular · 218d