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
161473–161496 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 05, 1982
IV FILTERSET 5 MICROMETER
K813445 · FPB
Imed Corp.
General Hospital · 27d
Cleared Jan 05, 1982
IV FILTERSET 0.22 MICROMETER
K813446 · FPB
Imed Corp.
General Hospital · 27d
Cleared Jan 05, 1982
I.V. FILTER-PREVENT
K813454 · FPB
Pioneer Viggo, Inc.
General Hospital · 26d
Cleared Jan 05, 1982
PUMP & DETECTOR
K813455 · FRN
Medlog GmbH Marketing Services
General Hospital · 36d
Cleared Jan 05, 1982
MONOJECT M560 60CC SYRINGES
K813480 · FMF
Sherwood Medical Co.
General Hospital · 35d
Cleared Jan 05, 1982
NON-ABSORBENT TOWELS
K813519 · KME
Cunningham Woodland, Inc.
General Hospital · 20d
Cleared Jan 04, 1982
ARIZONA RADIO CAPITELLAR TOTAL ELBOW
K812322 · JDB
Zimmer, Inc.
Orthopedic · 140d
Cleared Dec 31, 1981
CHEMFIL
K812858 · EMA
Dentsply Intl.
Dental · 79d
Cleared Dec 31, 1981
AGGLUTEX MORPHINE TEST KIT
K812985 · DDF
Hoffmann-La Roche, Inc.
Toxicology · 66d
Cleared Dec 31, 1981
AGGLUTEX BARBITURATES TEST KIT
K812988 · DKN
Hoffmann-La Roche, Inc.
Toxicology · 66d
Cleared Dec 31, 1981
MODEL TDS-2450-2 MICROWAVE DIATHERMY SYS
K813006
Technology Applications Group
Physical Medicine · 65d
Cleared Dec 31, 1981
CONNECTORS & ADAPTERS
K813074 · BYX
Seven Harvest Intl. Import & Export
Anesthesiology · 59d
Cleared Dec 31, 1981
UREOFIX 500 URINE MEASURING SYSTEM
K813082 · FFG
Burron Medical Products, Inc.
Gastroenterology & Urology · 59d
Cleared Dec 31, 1981
CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET
K813084 · KOB
Burron Medical Products, Inc.
Gastroenterology & Urology · 59d
Cleared Dec 31, 1981
ACCUPRO I.V. ADMINISTRATION SET
K813092 · FPA
American Mcgaw
General Hospital · 59d
Cleared Dec 31, 1981
SYSTEK #1 EIKEN
K813164 · JSS
Syn-Kit, Inc.
Microbiology · 51d
Cleared Dec 31, 1981
PHADEBAS/PHADEZYM IGE REAGENTS
K813189 · DGC
Pharmacia, Inc.
Immunology · 45d
Cleared Dec 31, 1981
GDC-1136 CASTING ALLOY FOR PORCELAIN-FU
K813200 · EJS
Ney
Dental · 48d
Cleared Dec 31, 1981
CASTLE #3241 GAS AERATOR
K813201 · FLI
Sybron Corp.
General Hospital · 48d
Cleared Dec 31, 1981
THERMALOG S STEAM STERILIZATION INTEGRA
K813202 · JOJ
Bio-Medical Sciences, Inc.
General Hospital · 48d
Cleared Dec 31, 1981
K51,K52 ENVIRONMENT ENCLOSURE
K813207 · LEJ
Kohler
Radiology · 43d
Cleared Dec 31, 1981
K60 HABITAT ENVIRONMENT ENCLOSURE
K813208 · LEJ
Kohler
Radiology · 43d
Cleared Dec 31, 1981
INTRAOSSEOUS DENTAL IMPLANT
K813227 · DZE
Pacific Implant, Inc.
Dental · 51d
Cleared Dec 31, 1981
CERAL-BASE METAL ALLOY
K813243 · EJH
Sillard Products, Inc.
Dental · 43d